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

May 18, 2004

VIA CERTIFIED MAIL

Re: My Client: Global Tronics International

Dear Ms. James:

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

Mr. Masry:

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.

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.

Dear Ms. James:

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

Mr. Masry:

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