DAPELLE HAIR REMOVER

K973773 · Wellquest Intl., Inc. · KCX · Dec 17, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973773
• Device Name: DAPELLE HAIR REMOVER
• Applicant: Wellquest Intl., Inc.
• Product Code: KCX · General, Plastic Surgery
• Decision Date: Dec 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5360
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

The Intended use for this product is to remove unwanted hair.

Device Story

Dapélle™ Hair Remover is a device intended for the removal of unwanted hair. It is indicated for prescription use. The device is operated by a healthcare professional to perform hair removal procedures. The document does not provide specific details regarding the input modality, energy source, or mechanism of action.

Clinical Evidence

No clinical data provided.

Indications for Use

Indicated for removal of unwanted hair. Prescription use per 21 CFR 801.109.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steven Mishan Vice President Welllquest International, Inc. 230 Fifth Avenue New York, New York 10001

DEC 17 1997

Re: K973773 Trade Name: Dapélle™ Hair Remover Regulatory Class: III Product Code: KCX Dated: September 29, 1997 Received: October 2, 1997

Dear Mr. Mishan:

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

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## Page 2 - Mr. Steven Mishan

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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F.KOM

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## K973773

December 9, 1997

Food and Drug Administration Center for Devices and Radiological Health NFZ-401 9200 Corporate Blvd Rockville, MD 20850

Indications for Use

## RE: 510 K - Dapelle Hair Remover - K-973773

The Intended use for this product is to remove unwanted hair.

Very truly yours

Steven Michen

Steven Mishan

signature

· Devices

Over-the-Count -

¥973773

x

**Prescription Use**
(Per 21 CFR 801.109)

WELLQUEST 230 Fifth Ave, NY, NY, 10001 212-689-9094 Fax [phone]

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