(90 days)
Not Found
No
The summary describes a light-based device for hair removal and does not mention any AI or ML components or capabilities.
No
The device is intended for permanent hair reduction, which is considered an aesthetic procedure, not a therapeutic treatment for a medical condition. While it has an intended effect (reduction of hair), it's not described as treating a disease or injury.
No
The device is designed for permanent hair reduction, which is a cosmetic procedure, not for diagnosing any medical condition or disease.
No
The device description explicitly states it is a "non-coherent light-based device," indicating it is a hardware device that uses light for treatment, not a software-only device.
Based on the provided information, the L600® device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- L600® Function: The L600® is a light-based device that directly interacts with the body (skin and hair follicles) to remove unwanted hair. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "photothermal removal of unwanted hair of the face and the body." This is a physical treatment applied to the body, not a diagnostic test performed on a sample.
Therefore, the L600® falls under the category of a therapeutic or aesthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / 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 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.
Product codes
GEX
Device Description
The L600® is a non-coherent light-based device designed for photothermal removal of unwanted hair.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
face and the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained skin professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The clinical data demonstrated that the device can be used effectively and safely by a trained skin professional.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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
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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