← Product Code [KCX](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX) · K973773 # DAPELLE HAIR REMOVER (K973773) _Wellquest Intl., Inc. · KCX · Dec 17, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K973773 ## Device Facts - **Applicant:** Wellquest Intl., Inc. - **Product Code:** [KCX](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX.md) - **Decision Date:** Dec 17, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.5360 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery - **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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. 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. {1}------------------------------------------------ ## 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 {2}------------------------------------------------ F.KOM Image /page/2/Picture/1 description: The image shows the word "WELLQUEST" in a stylized font. The letters "WELL" are in black on a white background, while the letters "QUEST" are in white on a black background. Above the word "WELLQUEST" is the text "(TUE) 12.09 '97 16:26". Image /page/2/Picture/2 description: The image contains a line of text that appears to be a document or record number. The text starts with a forward slash followed by "NO." and a series of numbers, specifically "300". There are also some additional characters and numbers after the initial sequence, including a ":" and ".3". The text is presented in a simple, sans-serif font, and the overall image has a clean, minimalist aesthetic. ## 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 212-213-1518 800-423-4248 米米木 END OF DOCUMENT 米米 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K973773](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KCX/K973773) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com