Global Tronics International Global Tronics makes cosmetic devices sold to salons. This page
only discusses their electric tweezer hair removal device sold
under the name Hair Tronics.
The Hair Tronics device manufactured
by Global Tronics International should be avoided by all consumers.
Here is an example of violative promotional material from a salon
which purchased the device and promotes it based on Global Tronics’
claims that FDA lists the device as permanent hair removal:
http://www.socalmall.com/arlbody.htm
“At Arleens we use Hair Tronics a FDA listed permanent
non-invasive method of gently removing unwanted facial and body
hair . This technique is accomplished by means of the custom-designed
tweezers utilizing gentle falvanic current. Hair removal without
pain. Permanent Hair Removal 15 minutes $12.50, 30 minutes $25.00"
Here are a couple of non-US examples:
http://www.plazaboricua.com/ileanairvine/espanol/tecno_info.htm
(Puerto Rico)
www.weddingsonline.ie/directory/company.asp (Ireland)
In 1998 the U.S. Food and Drug Administration (FDA) stated
that "there is no statistically significant scientific data
available at this time to support promotional claims of permanent
or long-term removal of hair through use of the device."
These devices have been available since 1959 with no published
clinical data indicating they can achieve permanent hair removal
as that term is generally understood by consumers.
Contact information
Contact: Michael Mantell Jr.
Address: VISUAL PROOF 123 Windsong St Thousand Oaks, CA 91360-2873
Telephone: (805) 492 -8946
(lawyer)
Address: Masry & Vititoe, 5707 Corsa Avenue, Second Floor
Westlake Village, California 91362
Telephone: (818) 991-8900
Fax: (818) 991-6200
Contact: EDWARD L. MASRY, ESQ.
website: http://www.MasryVititoe.com
email: SOVEIDA RODRIGUEZ <SRODRIGUEZ@MasryVititoe.com>
Global Tronics International threatens legal action
After putting up a consumer warning about this electric tweezer
scam, I received a threat from Ed Masry.
Masry is best known as the retirement-ready ambulance-chaser*
who was played with bumbling charm** in the film Erin Brockovich.
Below is our correspondence, with Masry's sloppy misspelling
left in place.
Re: My Client: Global Tronics International
Be advised that this office represents Global Tronics International
in regards to your continual illegal statements about their
products. Attached hereto you will find a memo to the record
of the FDA showing that their devise [sic] permanently removes
hair. Your reference to their product as a scam will not be
tolerated by my client or this office. You shall immediately
within 24 hours remove permanently any mention of Global Tronics
International from your website, or rest assured that no later
than one week from this date, you will be appropriately sued
in federal court.
Trusting I have made myself quite clear, I remain
Very truly yours,
MASRY & VITITOE
By: ___________/s/_____________________
EDWARD L. MASRY
ELM:sr
Enclosure
cc: Global Tronics International
I responded immediately upon receipt:
Your evidence that Global Tronics International has FDA clearance
to claim its tweezer type epilator achieves permanent hair
removal was not attached to your email.
In 1998 the U.S. Food and Drug Administration (FDA) stated
that "there is no statistically significant scientific
data available at this time to support promotional claims
of permanent or long-term removal of hair through use of the
device." (FDA Docket 97N-0199).
Please send evidence that your client’s device has been
cleared by FDA to make claims of permanent hair removal, or
I will assume your threats of a SLAPP suit are groundless
and without legal merit.
A Masry flunkie later sent the purported evidence, which was
some sort of internal memo written 12 years earlier.
I also contacted FDA about Global Tronics thanks to Masry,
and FDA sent this reply on 19 May:
If you carefully read the Reclassification FR (97N-0199)
you will see that FDA agreed that "there is no body of
significant information establishing the effectiveness of
the device to permanently remove hair." Furthermore FDA
stated that the agency still supported the down classification
of the device since we could address claims of "permanent"
hair removal via the misbranding provisions of the Federal
Food Drug and Cosmetic (FFD&C) Act. It is my understanding
that any language supporting "permanent hair removal"
whether in a 1992 510k clearance and/or in a 1992 Listing
report would be nullified by the subsequent (1998)reclassification
regulation. Do you have any literature or web link illustrating
that Global Tronics is actively promoting their product as
a permanent hair removal device. If so this product may be
misbranded under the FFD&C Act. I have directed this to
our Office of Compliance for any further action they deem
necessary. Do not hesitate to contact our office for any further
clarification.
I immediately sent FDA several examples of violative promotional
materials from Global Tronics per FDA's request. I would not
have done this had Mr. Masry not threatened me with a federal
SLAPP suit.
I then made two more attempts to get Mr. Masry to provide legitimate
evidence of his client's alleged FDA clearance following receipt
of my letter from FDA. Once Masry finally wandered into the
office in the late afternoon, he shot back with yet another
threat:
You have decided, without any research, to call my clients
a "scam". I am not sending you any information,
but I am making it very clear that next time you print anything
regarding my client, this office will, within five working
days, file an action in Federal Court for libel, unfair business
practices, etc.
I am not going to do your research. Unless you comply with
my request, rest assured that the next document you get from
me will be a Federal Subpoena.
Trusting I have made my position quite clear, I remain
Very truly yours,
MASRY & VITITOE
I am once again requesting that you provide evidence that
the Hair Tronics device is substantially equivalent to predicate
devices cleared by FDA as permanent. This claim does not match
the information I have in my records or information provided
by FDA.
After corresponding with FDA today, it is my understanding
that any language supporting "permanent hair removal"
whether in a 1992 510k clearance and/or in a 1992 Listing
report would be nullified by the subsequent (1998) reclassification
regulation.
I am making a good faith attempt to resolve this matter,
yet you continue to threaten me with a SLAPP suit.
I have done plenty of research on these devices and have
concluded that your client's device is in my opinion a scam.
In your zeal to threaten me, you have now brought your client’s
activities to the attention of federal authorities. If I were
Global Tronics, I’d consider a malpractice suit. Please
provide me with your client’s address so I can share
this development with them directly.
Andrea James
How to sue Global Tronics
If you have been scammed by someone selling this device or
treatments with it, please contact me, and I will send instructions
on how to sue them in small claims court.
From FDA's device listing database:
Device Classification Name EPILATOR, HIGH FREQUENCY, TWEEZER-TYPE
Regulation Number 878.5360
510(k) Number K915845
Device Name HAIR TRONICS MODEL HT8000
Applicant GLOBAL TRONICS INTL., INC. 2626 LAVERY CT.SUITE 301
NEWBURY PARK, CA 91320
Contact MANTELL, JR.
Product Code KCX
Date Received 12/26/91
Decision Date 07/29/92
Decision Substantially Equivalent
Classification Advisory Committee
General & Plastic Surgery
Review Advisory Committee
General & Plastic Surgery
Statement/Summary/Purged Indicator Statement/purged 510(k)
Type Traditional
Establishment Name: GLOBAL TRONICS INTL., INC.
2899 AGOURA RD., SUITE 139 WESTLAKE VILLAGE, CA 91364 US
Establishment Operations: Manufacturer
Owner/Operator Number: 9038966
Owner/Operator: GLOBAL TRONICS INTL., INC. 2899 AGOURA RD.,
SUITE 139 WESTLAKE VILLAGE, CA 91364 US
Official Correspondent Firm: GLOBAL TRONICS INTL., INC. 2899
AGOURA RD., SUITE 139 WESTLAKE VILLAGE, CA 91364 US
Establishment Status: Pending registration
Date of Registration Status: 09/07/99
Owner/Operator Phone Number: 888-387-6642
Official Correspondent Phone Number: 806-492-8396
Date Initial Registration Received: 09/02/99
Official Correspondent Name: MR. MICHAEL MANTELL
Note that statements on this page make no claims regarding
the Visual Proof microdermabrasion device sold by Global Tronics
International. This site only deals with epilation.
* Michael O'Sullivan Washington Post
** Bob Longino, Cox News Service
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