The LaserComb is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV.

Device Description

The LaserComb consists of a hand-held low level laser device that promotes hair growth. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. When in use, the device emits a beep every four seconds to notify the user to move the device to a new section of the scalp.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Lexington International, LLC LaserComb, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the clinical study's findings regarding the device's ability to promote hair growth and its safety profile.

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance
Efficacy	Significant increase in mean terminal hair density	Subjects in the LaserComb treatment group had significantly greater increases in mean terminal hair density than subjects in the placebo group.
	Significant improvement in overall hair regrowth (subjective)	Subjects in the LaserComb group also had significantly better subjective assessments of overall hair regrowth than subjects in the placebo group.
Safety	No serious adverse events	No subject experienced a serious adverse event.
	Adverse event profiles similar to placebo	The adverse event profiles were similar between the two treatment groups.
Functionality	Device functions as intended for proposed indication	In all instances, the LaserComb functioned as intended.
	Hair regrowth as expected	The hair regrowth observed was as expected.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a single number. The document refers to "subjects" in a multicenter clinical trial. To provide a precise number, further details from the full clinical study report would be needed. However, it was a "multicenter" trial, indicating a reasonable sample size across multiple locations.
Data Provenance:
- Country of Origin: United States ("conducted at four sites in the United States").
- Retrospective or Prospective: Prospective (clinical trial where subjects were enrolled and followed over time).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for the test set in the context of image analysis or diagnostic interpretation. The ground truth for efficacy was objectively measured (mean terminal hair density) and subjectively assessed by the subjects themselves (overall hair regrowth). For safety, adverse events were monitored.

4. Adjudication Method for the Test Set

Not applicable. The study design was a randomized, placebo-controlled trial. Efficacy endpoints were objective measurements (hair density) and subjective assessments by the subjects, not requiring expert adjudication of "ground truth" in the diagnostic sense. Safety endpoints involved adverse event reporting.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves multiple human readers evaluating cases with and without AI assistance to measure improvement in diagnostic performance. The LaserComb study focused on the direct physiological effect (hair growth) of the device versus a placebo, not on assisting human interpretation.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone study was done. The clinical trial evaluated the LaserComb device itself (algorithm/device only) in the treatment group compared to a sham device (placebo group). There was no "human-in-the-loop" component where the device was assisting a human operator in making a decision. The device directly delivers the therapeutic intervention.

7. Type of Ground Truth Used

The ground truth used for efficacy was:

Objective Measurement: Mean terminal hair density. This is a direct, quantifiable biological change.
Subjective Assessment: Subjects' self-assessment of overall hair regrowth.
For safety, the ground truth was based on reported adverse events.

8. Sample Size for the Training Set

Not applicable/not provided. This device is a therapeutic device, not an AI algorithm that requires a separate "training set" for model development. The clinical study serves as the primary validation of its efficacy and safety.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of an AI algorithm developer. The device's mechanism is based on low-level laser therapy, and its performance (efficacy and safety) was established through the described clinical trial.

Summary

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K 060305

510(k) SUMMARY

Lexington International, LLC LaserComb

Submitter's Contact Information

Name:	David Michaels, Managing Director	JAN 1 8 2007
Address:	Lexington International, LLC2650 North Military Trail, Suite 360Boca Raton, FL 33431
Telephone:	(561) 417-0200
Facsimile:	(561) 892-0747
Name of Device and Name/Address of Sponsor

Trade Name: HairMax LaserComb

Sponsor ContactInformation:	David MichaelsLexington International, LLC2650 North Military Trail, Suite 360Boca Raton, FL 33431
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Common or Usual Name: Lamp, nonheating, for promotion of hair growth.

Classification Name: Infrared lamp per 21 CFR 890.5500

Predicate Devices

Device Trade Name Robi Combi DermaLight Psoracomb Quantum WARP 10 Light Delivery System Lumiphase-R TerraQuant MQ2000 Laser Therapy Device MLT R694 Ruby Laser System L600 Hair Removal Violet Ray Device Vacuum Cap Raydo and Wonder Brush

Manufacturer Epilady 2000, LLC Solitec GMBH Quantum Devices, Inc. Opusmed Inc. Escada International, Inc. Medical Laser Technologies Ltd. A&M Technology Manufacturer unknown Evans Dr. Scott

Date Prepared:

September 27, 2006

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Intended Use / Indications for Use

The LaserComb is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV.

Technological Characteristics

Performance Data

A multicenter, randomized, placebo-controlled trial was conducted at four sites in the United States. Subjects received either the LaserComb or a sham device. Subjects were instructed to use the device times per week on nonconcurring days for a total of 26 weeks. Subjects in the LaserComb treatment group had significantly greater increases in mean terminal hair density than subjects in the placebo group. Subjects in the LaserComb group also had significantly better subjective assessments of overall hair regrowth than subjects in the placebo group. No subject experienced a serious adverse event and the adverse event profiles were similar between the two treatment groups. In all instances, the LaserComb functioned as intended and the hair regrowth observed was as expected.

Substantial Equivalence

The LaserComb is as safe and effective as a combination of those predicate devices. The LaserComb has the same intended use of affecting hair growth as its preamendments hair growth predicate devices and its laser hair removal predicates. In addition, the LaserComb has the same general indications, i.e., treating baldness, and the same specific indication of promoting hair growth as its preamendments predicate devices. The LaserComb also has many of the same or similar technological characteristics as a combination of its predicate devices, including its red laser wavelength, its split beam laser delivery system, its comb component, and its audible timer. The technological differences between the LaserComb and its predicate devices. namely use of red laser to promote hair growth, do not raise new questions of safety or effectiveness for several reasons. First, the safety and effectiveness profile of that type of laser is well-established. Second, FDA's clearance of a red laser with virtually the same wavelength (for a cosmetic-type indication) confirms the favorable risk benefit ratio of red lasers, even when they are used for cosmetic-like indications. Finally, the clinical data summarized in the 510(k) notice confirms the safety and effectiveness of the LaserComb for OTC use in promoting hair growth in its intended patient population, despite those technological characteristics. For those reasons, the LaserComb satisfies FDA's substantial equivalence with respect to both the intended use and technological characteristics.

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060305

There are some technological differences between the LaserComb and its predicate devices. Namely, none of the predicate devices deliver laser light to the scalp to promote hair growth. For this reason, Lexington conducted a clinical study of the LaserComb to show that the device functions as intended for its proposed indication without serious side effects.

The clinical data demonstrates that the LaserComb is effective in promoting hair growth and does not present any safety issues. Therefore, the LaserComb satisfies FDA's substantial equivalence criteria. Thus, FDA should clear the device via the 510(k) notice containing clinical data.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized depiction of a caduceus, a symbol often associated with medicine and healthcare. The caduceus in the seal is a modern interpretation, representing health and well-being. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lexington International, LLC % King & Spaulding, LLP Mr. Edward M. Basile Senior Partner 1700 Pennsylvania Avenue, Northwest Washington, District of Columbia 20006-4706

Re: K060305

Trade/Device Name: HairMax LaserComb Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, Non-Heating for Hair Growth Regulatory Class: II Product Code: OAP Dated: September 29, 2006 Received: September 29, 2006

Dear Mr. Basile:

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.

JAN 1 8 2007

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 (OS) 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. Edward M. Basile

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 (240) 276-0115. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): /< 060 30 30 30 30

Device Name: HairMax LaserComb

Indications for Use:

The LaserComb is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millman

Vision Sign-Off) Division of General, Restorative and Neurological Devices

:(k) Number K06.0305

WDC_IMANAGE-805437 v1-11743.189001

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.