(90 days)
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.
The L600® is a non-coherent light-based device designed for photothermal removal of unwanted hair.
Here's an analysis of the provided text regarding the A&M Technology L600® Photoepilation System's acceptance criteria and studies, based on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the L600® Photoepilation System. Instead, it relies on a determination of "substantial equivalence" to predicate devices. The performance data presented is a general statement about safety and efficacy without quantifiable metrics.
| Acceptance Criteria (Not explicitly stated in K030480) | Reported Device Performance (from K030480) |
|---|---|
| Implicit Criteria for Substantial Equivalence: | The clinical data demonstrated that the device can be used effectively and safely by a trained skin professional. |
| - Demonstrate safety equivalent to predicate devices | (Implicitly met by the safety findings of the clinical data) |
| - Demonstrate efficacy (permanent hair reduction) equivalent to predicate devices | (Implicitly met by the efficacy findings of the clinical data) |
Definition of Permanent Hair Reduction (from K030480): A long-term and stable reduction in the number of hair follicles 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.
Regarding the Absence of Detailed Criteria:
It's important to note that 510(k) submissions often focus on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing new, specific performance criteria. The FDA's letter confirms that they reviewed the submission and found the device substantially equivalent for the stated indications. This implies that the provided clinical data, even if not numerically detailed in this summary, was deemed sufficient to support this claim in comparison to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size for any clinical test set. It mentions "clinical data" in a general sense.
The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide any information regarding the number of experts used to establish ground truth for a test set or their specific qualifications. It only generally states that the device is to be used by a "trained skin professional."
4. Adjudication Method
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. There is no mention of human readers, AI assistance, or an effect size for improvement.
6. Standalone (Algorithm Only) Performance Study
This device, the L600® Photoepilation System, is a physical medical device (an intense pulsed light system), not an AI algorithm. Therefore, the concept of a "standalone (algorithm only) performance study" is not applicable to this product.
7. Type of Ground Truth Used
The document does not explicitly define the type of ground truth used for evaluating "permanent hair reduction" in its clinical data. Given the nature of hair removal, it would typically involve:
- Clinical observation and measurement: Direct counting of hair follicles in treated areas, potentially using standardized photography or dermatoscopic examination to assess hair density and regrowth over time.
- Patient self-assessment/satisfaction: Though less objective, this can be part of clinical evaluation.
8. Sample Size for the Training Set
The concept of a "training set" typically applies to machine learning algorithms. Since the L600® is a physical device, there is no training set in the context of an algorithm. If "training set" refers to the subjects involved in establishing the clinical efficacy for the device itself, this information is not provided in the summary.
9. How the Ground Truth for the Training Set Was Established
As explained above, the concept of a "training set" for an algorithm is not applicable. For the clinical evaluation of the device, the establishment of "ground truth" (i.e., confirmation of permanent hair reduction) would likely follow standard dermatological assessment methods, as mentioned in point 7, but this is not detailed in the provided summary.
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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 DANETApplication Specialist28, rue de la Trémoille75008 ParisFrance |
|---|---|
| Telephone : | 00 33 1 56 89 10 40 |
| Fax : | 00 33 1 56 89 10 49 |
| 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 surgeryand 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.
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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™
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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.
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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
§ 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.