← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K030480 # L600 HAIR REMOVAL (K030480) _A&M Technology · GEX · May 14, 2003 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K030480 ## Device Facts - **Applicant:** A&M Technology - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** May 14, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The L600® is a non-coherent light-based device designed for photothermal removal of unwanted hair of the face and the body in skin types I to IV through selective targeting of melanin in the hair follicle. The L600® is intended to effect permanent hair reduction. ## Device Story L600® is a non-coherent light-based system for photothermal hair removal; targets melanin in hair follicles to achieve permanent hair reduction. Operated by trained skin professionals in clinical settings. Device delivers light pulses to skin; thermal energy absorbed by melanin destroys hair follicles. Clinical efficacy and safety demonstrated for skin types I-IV. Output used by clinicians to guide treatment parameters; permanent hair reduction defined as stable, long-term reduction in hair follicle regrowth beyond a complete growth cycle. ## Clinical Evidence Clinical data provided to demonstrate safety and effectiveness for permanent hair reduction in skin types I-IV when used by trained skin professionals. No specific statistical metrics (e.g., p-values, AUC) provided in the summary. ## Technological Characteristics Non-coherent light-based system; photothermal energy source; designed for skin types I-IV; targets melanin in hair follicles. ## Regulatory Identification (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon. ## Predicate Devices - Estelux™ ([K020453](/device/K020453.md)) - Radiancy Spa Touch™ ([K020856](/device/K020856.md)) ## 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}------------------------------------------------ # 510(k) SUMMARY MAY 1 4 2003 L600® Photoepilation System KO30490 # Submitter's name, address, telephone number, contact person and Date A&M Technology SAS 76-78 Av des Champs Elysées 75008 Paris France 00 33 1 56 89 10 40 Telephone : 00 33 1 56 89 10 49 Fax : | Contact person : | Pascal DANET
Application Specialist
28, rue de la Trémoille
75008 Paris
France | |------------------|--------------------------------------------------------------------------------------------| | Telephone : | 00 33 1 56 89 10 40 | | Fax : | 00 33 1 56 89 10 49 | | Email | pdanet@am-technology.com | January 28, 2003 Date Prepared : #### Name of Device | Device Trade Name: | L600® system | |----------------------|----------------------------------------------------------------------------------------| | Common name: | L600® Intense Pulsed Light Hair Removal System | | Classification Name: | Laser surgical instrument for use in general and plastic surgery
and in dermatology | | Product Code: | GEX | | Regulation Number: | 878 4810 | ### Predicated Devices Palomar Medical Technologies, Inc : Estelux™ ; K020453 Radiancy Spa Touch™; K020856 ## System Description The L600® is a non-coherent light-based device designed for photothermal removal of unwanted hair. #### Intended Use The L600® is a non-coherent light-based device designed for photothermal removal of unwanted hair of the face and the body in skin types I to IV through targeting of melanin in the hair follicle. The L600® is intended to effect permanent hair reduction. {1}------------------------------------------------ # Comparing technical characteristics/ Performance Data The differences in the specification of the L600® and the predicate device do not result indifferent performance or raise any new questions of safety or efficacy. The clinical data demonstrated that the device can be used effectively and safely by a trained skin professional. ## Summary Based on the foregoing, we believe that the L600® is substantially equivalent to the legally marketed predicate devices, the Estelux™ or the Spa Touch™ {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure with three stylized human profiles forming the body and wings. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 4 2003 Mr. Pascal DANET Applications Specialist A&M Technology 28, rue de la Tremoille F 75008 PARIS Re: K030480 Trade/Device Name: System L600® Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 3, 2003 Received: February 13, 2003 Dear Mr. Danet: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Mr. Pascal DANET This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Muriam C. Provost Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 1 of 1 | Applicant: | A&M Technology SAS | |---------------------------|--------------------| | 510(k) Number (if known): | K030480 | | Device Name: | System L600® | Indications for Use: The L600® is a non-coherent light-based device designed for photothermal removal of unwanted hair of the face and the body in skin types I to IV through selective targeting of melanin in the hair follicle. The L600® is intended to effect permanent hair reduction. According to the Food and Drug Administration, permanent hair reduction is defined as a long term and stable reduction in number of hair follicle re-growing after a treatment regime. The number of hair re-growing must be stable over time greater than the duration of a complete growth cycle of hair follicles according to body location. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Miriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K030480 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K030480](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K030480) **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. 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