TWEEZER-TYPE EPILATOR

K970338 · Igia Direct, Inc. · KCX · Jul 1, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970338
• Device Name: TWEEZER-TYPE EPILATOR
• Applicant: Igia Direct, Inc.
• Product Code: KCX · General, Plastic Surgery
• Decision Date: Jul 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5360
• Device Class: Class 1

Indications for Use

The sole indication for use of this Class III Tweezer-Type Epilator medical device is for the removal of undesired body hairs using the techniques described in the Owner's Instruction Brochure.

Device Story

Elysee Hair Removal System is a tweezer-type epilator. Device functions by grasping individual hairs and applying mechanical force to remove them from the follicle. Used by consumers in home setting for cosmetic hair removal. Output is physical extraction of hair. Benefits include temporary removal of unwanted body hair.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Tweezer-type epilator; mechanical operation; handheld form factor; no software or electronic processing.

Indications for Use

Indicated for removal of undesired body hair. Intended for over-the-counter use.

Regulatory Classification

Identification

The tweezer-type epilator is an electrical device intended to remove hair. The energy provided at the tip of the tweezer used to remove hair may be radio frequency, galvanic (direct current), or a combination of radio frequency and galvanic energy.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

IGIA DIRECT, Inc.
c/o James R. Marshall, Ph.D.
President
The Thera Group
4310 Hunters Pass
Brooksville, Florida 34609

JUL 1 1997

Re: K970338
Trade Name: Elysee Hair Removal System
Regulatory Class: III
Product Code: KCX
Dated: April 30, 1997
Received: May 6, 1997

Dear Dr. Marshall:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for

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devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Food and Drug Administration
Document Mail Center (HFZ-401)
9200 Corporate Blvd.
Rockville, MD 20850

RE: Amendment to 510-k #K970338

1. Indications For Use Statement:

The sole indication for use of this Class III Tweezer-Type Epilator medical device is for the removal of undesired body hairs using the techniques described in the Owner's Instruction Brochure.

Sincerely,

For: Igia Direct, Inc.


James R. Marshall, Ph.D.
President, The Thera Group

Over-the-Counter Use ☑