How Similar is the Nu Skin Facial Spa to the Nu Skin Galvanic Spa

[Brian Curry]

Read ALL the way down to the bottom here.  This is long, and has questions and responses and some analysis of "What does it all mean???"  Also there was some recent info from Anganel Davis on a Conference Call.

This will address the "technical" issues.  This has the supporting documents from Nu Skin Corporate sources, or US Government documents.  Word tracks?  Listen to your team leader calls or the various General's Calls, Team Aloha Calls, etc

However, the basic message.  The Galvanic Spa and the Facial Spa are effectively the same but "different" in VERY slight details.

Now to the tech details.  I sent the inquiry below to Product support and got this response

---------- Forwarded message ----------
From: <PRODUCTS...@nuskin.com>
Date: Thu, Sep 4, 2014 at 4:08 AM
Subject: RE: New Facial Spa questions
To: bmwb...@gmail.com

Brian,

Thank you for contacting Product Support.  In regard to the Facial Spa Science Video, you are correct in your observations.  The target audience was not designed for those with engineering backgrounds.  Because of this, Dr. Kern attempted to simplify the overarching science principles for lay consumers.  We are readily aware of the differences between voltage and currents but appreciate you taking the time to check with us.

In regards to your questions:

First, for specific technical information about the Facial Spa’s currents, please see the attached documents.  This information will be included in the Facial Spa’s User Manual for reference.

Second, the Facial Spa will have a total of five different settings.  Each Facial Spa regimen will contain two different sessions– one negative and one positive.  The different settings combinations are designed for the general and area regimens.  Details and uses of the settings will be outlined and explained in the User Manual that is included with the Facial Spa.  Unfortunately, the User Manual is not available online; however, please reference the Instructional and Demonstration videos available on our website.

Finally, the Facial Spa does not use the same pulsating technology as the Body Spa.  The Body Spa utilizes this technology to better address the structural differences and targeted attributes that are unique to other areas of the body (i.e. thicker and less sensitive skin) other than the face.

I hope this information is helpful. If you have further questions, please contact Nu Skin Product Support at 1-800-487-1000 or by e-mail at products...@nuskin.com.

Sincerely,

Steven

NSE Product Support

[Spa Specs 1.png and Spa Specs 2.png files where attached to this reply.]

Original Text

From:	bmwb...@gmail.com
To:	PRODUCTS...@nuskin.com
CC:
Sent:	08/29/14 14:30:26
Subject:	New Facial Spa questions

Greetings Product Support,

I hope you can help me with some questions about the new Facial Spa.
Some of the information that has been presented is confusing.

In Nu Skin developed Power Point file "facial_spa_presentation.pptx"
slide five (5), Dale Kern in the "Nu_Skin_Facial_Spa_Science_Video"
(https://www.nuskin.com/content/nuskin/en_US/products/facial_spa/science_video.html)
at ~1 min 40 sec mark says that the chart in the upper left indicates
a low current. This is incorrect. The chart in the upper left shows
a constant 12 VOLTS, not current at all. Further 12 volts is not that
low a voltage. The chart in the upper right (~1min 43 sec in the
video) again shows voltage not current. In this case a peak voltage
of ~170V. (It appears it was taken from an illustration showing the
relationship of RMS voltage to peak voltage.) Five microvolts
(0.000005V) is a low voltage. Five hundred thousand volts (500,000V)
is a high voltage. I have been close to both of them. NONE of them
is a current. Current is measured in amps not volts.

In same Power Point file, slide Six (6) shows various wave forms and
polarity that voltage or current can be applied in. Again one of the
illustrations is about voltage not current. (This is mentioned at
~2min 6 sec mark in the same video) The ordinate caption in the top
centered illustration is "VOLTAGE (V)" not current.

That said, it takes an applied voltage to cause a resulting current.

Here are my questions:

1) Are the currents caused by the new Facial Spa automatically
adjusted for the skin/tissue resistance like the Galvanic Spa does?
Is the applied current(s) at similar levels to the Galvanic Spa?

2) Is the new Facial Spa like the Body Spa where there is "one
setting" or are there different settings?

3) If there are different settings, how many are there?

4) If there are different settings, do they differ in polarity (One is
positive, one is negative, etc)?

5) From the emphasis on wave form, it appears the Facial Spa applied
currents are not constant as the Galvanic Spa applied, but are pulsed
or varied as the Body Spa does. Is this a correct understanding?

6) Assuming there are different settings, different polarities, and
some varying waveform, does each setting keep to one polarity at a
time, or are there settings where the polarity is positive at one
point and negative at some later point. If there is a single setting,
with some applied waveform, is the polarity constant or does it vary
between positive and negative?

7) Are the new Facial Spa written use instructions available somewhere?

I am looking forward to your response.

THNX.

--

Brian Curry, BSEE, PE

#####

Note that I brought up the issues with the illustrations and that I am an EE only for credentialization purposes.  I KNOW electricity, particularly simple electricity like we have here.  I did not want to get blown off with some standard fluff response.
This caused me to ask another question and got another response

===


---------- Forwarded message ----------
From: <PRODUCTS...@nuskin.com>
Date: Fri, Sep 5, 2014 at 4:48 AM
Subject: RE: Re: New Facial Spa questions
To: bmwb...@gmail.com

Brian,

Thank you for your reply.  You are correct that the Facial Spa utilizes a direct microcurrent rather than a pulsating current.  Let us know if there is anything else that we can do for you.

Sincerely,

Steven

NSE Product Support

Original Text

From:	bmwb...@gmail.com
To:	PRODUCTS...@nuskin.com
CC:
Sent:	09/04/14 14:50:55
Subject:	Re: New Facial Spa questions

On Thu, Sep 4, 2014 at 4:08 AM, <PRODUCTS...@nuskin.com> wrote:

> Finally, the Facial Spa does not use the same pulsating technology as the Body Spa. The Body Spa utilizes this technology to better address the structural differences and targeted attributes that are unique to other areas of the body (i.e. thicker and less sensitive skin) other than the face.
>
> I hope this information is helpful. If you have further questions, please contact Nu Skin Product Support at 1-800-487-1000 or by e-mail at products...@nuskin.com.
>
> Sincerely,
>
> Steven

First, Thank You very much for your response. I have one additional
question coming out of the paragraph above and the "Spa Specs1.png"
file attached.

The Spa Specs1 file says that the Output Waveforms are "DC Voltage".
Is that indicating that it does not pulse at all, but is constant?
(Ignoring any startup transients noted in the other attachments.)

THNX Again.

--

--------------------------------------
Ambassador BMW MOA |
Brian Curry | The people should obey the rules,
"DEERsSLAYER" | but not know about them.
K75RTs both coasts | -- Aizawa Seishisai
Chester Springs PA |

#####

Now what do we have here.  First the output "waveform" is a DC current just like the old(er) Galvanic Spas. (Spa Specs 1 file, FDA Clearance Letter and the response)


​​
Now how many settings and what are the times for them in the new Facial Spa?  From Spa Specs 2 file there are Five Settings just like the "old" spa.  (The older spa you  could get six settings either of the two polarities, and then 2, 3, or 5 minutes at the two polarities.)


​​

There is only "one current level" with the Facial Spa.  The "one, two or three beeps" is no longer indicating if you have a low, medium or high micro current being applied.  It is NOT automagically adjusting the current.

The "one current level" is also confirmed by examining page 4 of the FDA Clearance Letter.  (Facial Spa FDA Clearance K122711.pdf)

Now the Galvanic Spa had three US Patents covering it, Patents 6119038, 6766199, and 7350269 (THNX Ella Siroskey)  They are attached here.  Patent 6119038 was the first patent for the spa, and it has a few more years to run.  It speaks of a recharging system, that the first Nu Skin Galvanic Spas had.  It had only ONE head.

The second Patent Patents 6766199 is for interchangeable heads for the spa.  This is where the body head and hair head which are NOT included in the new incarnation showed up.  Page 11 second column has the meaty bits.  It says there could be three current levels, LOW, MEDIUM, and HIGH which are nominally 0.25 milliamps, 0.375 milliamps, and 0.5 milliamps.  It also says "Furthermore, the MEDIUM current level is used as the preferred default current level."

The third  Patent 7305269, has a number of details on the electrical connections to the heads, how the heads are held on and also some other shapes that it could be.  The other shapes are the hints to the Body Spa.

If the new Facial Spa has some new patents associated with it, let me know the new numbers, and I will dig out the info on what they say, and see if there is any impact to us.

---

Notice that the MEASURED currents on file Spa Specs 2 and FDA Clearance Letter are about the same as the MEDIUM current in the patent.  That medium current is the preferred current and now what the Facial Spa puts out.  The Spa Specs 2 and FDA Clearance Letter values are nominally the same as the Patent MEDIUM values.  So, the Facial Spa is using the preferred default current level.

So, the old spa had the same times, and if you got two beeps the same current as the new Facial Spa.  Are the polarities the same as the old spa at the various settings?  I can't tell w/o testing, but I bet they are.

One significant thing that I picked up from the instructional video https://www.youtube.com/watch?v=UdpWdhi0pdI   The new Facial Spa STILL gives the one, two or three beeps indicating the skin resistance/impedance.  However, the current is the SAME for all three 'beep levels" based on that DATA table in Spa Specs 2 and the FDA Clearance Letter.  One use for the beep indications:  A new person who does not routinely use a moisturizer, is likely to be a "one beep" with dry, high resistance/impedance skin.  With consistent use of a Nu Skin moisturizer, their skin should become moister, with lower resistance/impedance and so getting two or three beeps.  (Note this is NOT assured.  It seems that some skin types are high resistance/impedance no matter what.  However, if you note they started out at one beep and now are at more, it is a positive talking point. "Your skin has gotten moister!")

There appear to be darn few differences between the old(er) Galvanic Spa and the Facial Spa.

Someone has said the the FDA wanted the current to be both polarities or "alternating", not just one polarity.   The current coming from an outlet in your house has both polarities positive and negative just like a Galvanic Spa can have.  They change 60 times a second, or 60 cps, or 60Hz.  Each cycle runs about 16.66 milliseconds.  Positive for approximately 8.333 milliseconds, and negative for the next 8.333 milliseconds.  Now if one 5 minute setting is positive and one 5 minute setting is negative, one could say that you are applying an "alternating current".  Rather than being 60 cps or 60Hz, it is 0.0016667 cps or 0.0016667Hz.  That is a VERY low frequency alternating (AC) current but it IS alternating.  You just have to squint your eye the right way, align it right with the light and get the right angle on it. :):)

So, if we apply it for 5 minutes at one polarity, and then set it for the other polarity and apply again, we are applying an "alternating current" to the skin.

View the instructional video and see for yourself: https://www.youtube.com/watch?v=UdpWdhi0pdI

If that rumored FDA request is correct, the person in Nu Skin that came up with that interpretation is BRILLIANT!

---

What clues do we have about the differences between the new and old gels.  Notice I say clues, because the amount of DATA is less on the gels.  A local person noted that the new "first gel" tube does not have any ageLOC markings on it.  The second gel DOES have the ageLOC markings on it.  Someone else said that in the case of the first gel, Nu Skin purchased/sourced one already on the market that ALREADY had FDA clearance.  Anganel Davis said the same thing on a Conference Call Wednesday 11 September 2014.  Thus the first Facial Spa gel is also FDA cleared like the Facial Spa.

The only concern I might have is that the late Penelope Staley held that the "magic was in the gels".  She could buy "conventional" galvanic gels by the quart/liter for cheap.  However, they did not have the same effect as the Nu Skin Galvanic gels.  Now there might be "conventional" and "conventional" gels some being different and better than others.  Nu SKin may have tested all of them, and found one that had the "right or better effects."

Or the real magic might have been in the second blue tube gel which was the "ageLOC'd" gel, not the first Gel.  The real magic now may be in the second gel applied AFTER the Facial Spa treatment.

Also, there is something else that Nu Skin made a Patent Application for, but nothing seems to have been done with it.  That is Patent Application number 20070185431  They found that by putting a "micro current" through the skin it increases the absorption of anything applied to the skin for up to 48 hours.  (They got tired of taking data, and it was not automated, at that point.)  The DATA in the Patent Application is the basis for the claim that the company gave us.

The Facial Spa micro current treatment with the already cleared gel may be setting up the skin for improved absorption, and effects of the new second ageLOC gel.

It may be that the "face lift" effect we saw with the old(er) Galvanic Spa was due to the micro current stimulation of the skin and ours is "better" than the other TENS devices for aesthetic purposes due to the methods (heads) used.  (See the other device clearances and do some Google work on what they look like and how they were used.)  Our Facial Spa with micro currents is a LOT easier to use than the other systems out there.  (I think it looks a LOT better too.)

Could some of what we are hearing be "marketing"?  Yes, it could be.  We could be being trained on what to say to DIFFERENTIATE the Galvanic Spa from the Facial Spa to keep the FDA/lawyers happy.  That is a GOOD THING.

It has been alluded to that if they had tried to get the Galvanic Spa approved as a Galvanic Device rather than a TENS device for aesthetic purposes, it could have taken YEARS rather than the year it did take.  It is possible.  That might be a "new class" of device that someone else has not broken the ground for.  It might be that it would take exten$$ive and expen$$ive and time con$$uming trial$ for the FDA to say "Enough, you can market it as a Galvanic Spa."  Ask the drug companies how much they enjoy that EXPEN$$$IVE process and then remember what new drugs cost.  Those development costs have to be recouped somehow.  The recoupment comes from the drug's price.  Do we want a more expen$$ive spa and gels sometime in the indeterminate future??  I think not.

The company MAY drive it forward as a Galvanic device in the background, and do another relaunch some time in the future.  Meanwhile we can be BUILDING BUSINESS.

I found this quote about "approved" versus "cleared"

"Many medical devices, including the XXXX products now under scrutiny, are not required to go through the rigorous approval process that drugs must face in order to win FDA approval. The language is even different: drugs are “approved,” devices are “cleared” through what’s called the 510(k) process, which simply requires that the new device is shown to be “substantially equivalent” to a comparable device already on the market.

Under this scenario, there are generally no gold-standard safety and efficacy trials; no tests in humans."

That is why the Facial spa is "cleared" not approved.  It is CLEARED based on the experience with the "substantially equivalent" TENS devices already on the market.  Don't worry about it, don't fret over it, GO WITH THE FLOW and ACCEPT IT.  Yes, we have thousands of spas out there that have been used, that people have found to be efficacious, and I suspect NO bad effects, but "That does not count."  And you or Nu Skin will NOT win that argument or discussion.  Go with the flow.

However, for RIGHT NOW, the only question is does the "new" Facial Spa provide results similar to what were seen with the old(er) Galvanic Spa?  If it does, it changes to "What word tracks do I want to use now?"  Note that Nu Skin is saying "You will see results in one use."  First time for that.  That is not a distributor claim, but a company claim.  Would they say it, if it was not true?  Nu Skin has "deep pockets" which other lawyers love to lighten by suing for an inaccurate claim.

Worry about the important thing, the word tracks you will be using, not how similar the Facial Spa is to the old(er) spas.  It is very similar electrically, MOVE ON on that issue.  It is NOT a "step backward" or "downward".  It is the same but "different."

####

I dug out the Facial Spa  "clearance" paperwork some time back.  I checked the FDA site for the Facial Galvanic Spa registration.

Here is the URL for the site:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=41160
If you step one URL further to here:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=3403
you find these statements:
Device: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation Description: Transcutaneous electrical nerve stimulator for pain relief.

Read for yourself and see what the clearance says.  The PDF for clearance K122711 is attached.  It references other earlier "substantially equivalent" device clearances and all of them are attached until I found no further clearance numbers.

So, at this point, you know what Product support has said and provided, and the FDA Clearance Letter and my interpretation of that stuff.  (The Facial Spa is VERY similar to Galvanic Spa but different.) A discussion of a rumored "different polarity" requirement, and why we have that.  Some info on the new first FDA cleared gel.  Some speculation on gel differences and similarities.  Also a Patent Application with DATA backing up the Claim that applying a micro current to the skin will increase topically applied ingredient absorption for some time.  Lastly, there is a PDF of the FDA clearance, and also the clearances for preceding devices.

Unless we find that "The new Facial Spa does not produce the results the Galvanic Spa did" GET OVER IT, and figure out your word tracks, and train the lizard brain to say FACIAL SPA, not that older name...

It is now all about WORD TRACKS.

Oh, and if you have a technical person that wants all that info and DATA, you have all that stuff to hand to them to pour over.  They can read it on their own, you don't have to try to verbally convince them.

HTH.

--

--------------------------------------------------------------------
Ambassador BMW MOA   |
Brian Curry          |      The people should obey the rules,
"DEERsSLAYER"        |         but not know about them.
K75RTs both coasts   |      -- Aizawa Seishisai
Chester Springs PA   |