The HairMax LaserComb Advanced 7, HairMax Lux 9 and HairMax Professional 12 are indicated to treat androgenetic alopecia, promote hair growth and help prevent further hair loss in males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss and Fitzpatrick Skin Types I to IV.

Device Description

Substantially equivalent to the HairMax LaserComb (K060305, K093499), the modified HairMax LaserComb Advanced 7, HairMax Lux 9 and HairMax Professional 12 are handheld low level laser devices that emits laser light with the intention to promote hair growth. The devices provide 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. HairMax LaserComb Advanced 7, HairMax Lux 9 and HairMax Professional 12 replace the cleared version's single beam laser and beam splitting reflector with a circuit board containing seven, nine, or twelve laser diodes. respectively.

AI/ML Overview

The provided text describes clinical trials for the HairMax LaserComb devices, but it does not contain the level of detail typically found in a study proving a device meets specific acceptance criteria, especially for an AI/CADe device. The information is geared towards establishing substantial equivalence to previously cleared devices.

However, I will extract the information that is present and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for a new device's performance metrics (e.g., specific sensitivity, specificity, or accuracy thresholds). Instead, it focuses on demonstrating substantial equivalence to predicate devices in terms of safety and effectiveness. The reported performance relates to the effect of the device rather than specific diagnostic or analytical metrics.

Acceptance Criteria	Reported Device Performance (from multi-center clinical trials)
Safety: Device adheres to electrical and EMC safety requirements.	Confirmed adherence to IEC 60601-1 and 60601-1-2.
Laser Classification: Laser classification is Class 3R.	Confirmed adherence to IEC 60825 (Class 3R).
Effectiveness: Promote hair growth in males with androgenetic alopecia (Norwood-Hamilton IIa-V, Fitzpatrick I-IV).	Expected to provide an effective dose rate to promote hair growth.
Effectiveness: Prevent further hair loss in males with androgenetic alopecia (Norwood-Hamilton IIa-V, Fitzpatrick I-IV).	Expected to help prevent further hair loss.
Overall substantial equivalence (Safety & Effectiveness): Compared to predicate devices (K060305, K093499).	Safety and effectiveness outcomes substantially equivalent to predicate devices.
Usability: User manual is validated, and device modifications do not affect safe and effective use.	Device and manual validated within a sample population. Modifications do not affect safe and effective use compared to predicates.

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

The document mentions "Two randomized, double-blind, controlled, multi-center clinical trials" were conducted.

Test Set Sample Size: The exact sample size for these clinical trials is not provided in the given text.
Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: "randomized, double-blind, controlled, multi-center clinical trials" are inherently prospective studies.

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

This information is not provided in the given text. The studies evaluated changes in "terminal hair-count in the evaluation zone," which implies objective measurement rather than expert consensus on a diagnostic image.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with vs. without AI assistance was not done, nor would it be relevant for this type of device. The HairMax LaserComb is a therapeutic device, not an AI/CADe diagnostic tool that assists human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The HairMax LaserComb is a physical therapeutic device, not an algorithm. Its performance is assessed as a standalone device used by a human, but there is no "algorithm only" performance to evaluate in this context. The clinical trials evaluated the device's effect on hair growth in patients.

7. The Type of Ground Truth Used

The ground truth used in the clinical trials was likely based on objective measurements of hair growth (e.g., changes in terminal hair count, possibly photographic assessment, or other standardized dermatological metrics to assess hair density and growth). The document mentions "evaluating changes in terminal hair-count in the evaluation zone." This falls under outcomes data or objective clinical measurements.

8. The Sample Size for the Training Set

This question is not applicable in the context of the provided text. The HairMax LaserComb is a physical medical device, not an AI/ML algorithm that requires a "training set." The clinical trials served as the verification and validation studies for the device's performance.

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

This question is not applicable, as there is no "training set" for this type of device.

Summary

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Section 5: 510(k) Summary

APR - 6 2011

The following information is provided as required by 21 CFR § 807.87 for Lexington International. LLC HairMax LaserComb Advanced 7. HairMax LaserComb Lux 9 and HairMax LaserComb Professional 12 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990. the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

Sponsor: Lexington International, LLC 777 Yamato Rd. Suite 105 Boca Raton, FL 33431
Olsson Frank Weeda Contact: Casper E Uldriks Esq. 1400 Sixteenth Street, NW Suite 400 Washington DC 20036 Ph. 202-518-6385 culdriks@ofwlaw.com

Date of Submission: November 16, 2010

Proprietary Name: HairMax LaserComb Advanced 7. HairMax LaserComb Lux 9 and

HairMax LaserComb Professional 12

Common Name: Lamp. non-heating, for promotion of hair growth

Regulatory Class: II

Product Codes: OAP

Predicate Device(s): Lexington International, LLC HairMax LaserComb K060305 and K093499

Device Description:

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single beam laser and beam splitting reflector with a circuit board containing seven, nine, or twelve laser diodes. respectively.

Intended Use:

Technological Characteristics

The HairMax LaserComb Advanced 7, HairMax Lux 9 and HairMax Professional 12 consist of a hand-held low level laser devices that promotes hair growth. The device provides distributed laser light to the scalp while the device's 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 (9 and 12 laser models) or vibration (7 laser model) every four seconds to notify the user to move the device to a new section of the scalp.

Performance Testing

Testing to IEC 60601-1 and 60601-1-2 confirm the device's adherence to LVD electrical and EMC safety requirements. Testing to IEC 60825 confirm the laser classification to be Class 3R, same as predicate devices.

Clinical Testing

Two randomized, double-blind, controlled. multi-center clinical trials were conducted to confirm the performance of the subject devices. These studies confirm that the subject devices are expected to provide an effective dose rate to promote hair growth in males with androgenetic alopecia who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and Fitzpatrick Skin Types I to IV with safety and effectiveness outcomes substantially equivalent to those of the predicate devices.

Additionally, a study was conducted to validate the HairMax LaserComb User Manual (Copyright 2009) for the Lux 9, Professional 12 beam unit and confirm usability. Participants in the study were given access to the HairMax LaserComb and the User Manual under controlled conditions. Based on the study outcomes, the device and manual were validated within a sample population that could potentially desire to use the HairMax LaserComb.

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Substantial Equivalence

The HairMax LaserComb Advanced 7. HairMax Lux 9 and HairMax Professional 12 are as safe and effective as the predicate devices. The HairMax LaserComb Advanced 7. HairMax Lux 9 and HairMax Professional 12 have the same intended use of promoting hair growth as the predicate devices. The subject devices have the same general indications, i.e., treating androgenetic alopecia, and the same specific indication of promoting hair growth in males with androgenetic alopecia who have Norwood-Hamilton Classifications of I to V patterns of hair loss as the predicate devices.

Except for modifications to the laser delivery method and slight increases in laser output, the HairMax LaserComb Advanced 7, HairMax Lux 9 and HairMax Professional 12 is identical in technological characteristics as the HMLC as cleared in K060305 and K093499, including its red laser wavelength, its comb component, its instructions for use and its audible or vibrating timer. The modification to the HairMax LaserComb Advanced 7, HairMax Lux 9 and HairMax Professional 12 does not change the intended use of the product nor does it affect the products fundamental scientific technology. Therefore this change does not raise new questions of safety or effectiveness. This was also demonstrated in randomized, double-blind, control clinical studies evaluating changes in terminal hair-count in the evaluation zone, as well as usability studies to validate instructions for use, confirm that device modifications do not affect the safe and effective use of the devices when compared to the predicates.

For those reasons, the HairMax LaserComb Advanced 7, HairMax Lux 9 and HairMax Professional 12 satisfy FDA's substantial equivalence with respect to both the intended use and technological characteristics.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with three overlapping profiles, resembling a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

777 77 11 11

Lexington International, LLC % Olsson Frank Weeda Casper E. Uldriks, Esq. 1400 Sixteenth Street. Northwest Washington, District of Columbia 20036

Re: K103368

Trade/Device Name: HairMax LaserComb Advanced 7, HairMax LaserComb Lux 9 and HairMax LaserComb Professional 12

Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP Dated: January 26, 2011 Received: March 15, 2011

Dear Mr. Uldriks:

This letter corrects our substantially equivalent letter of April 6, 2011.

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

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Page 2 - Casper E. Uldriks, Esq.

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. 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, perforts 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.

Aly B. Rata

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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Section 4: Indications for Use Statement

510(k) Number: To be assigned Device Name: HairMax LaserComb Advanced 7, HairMax LaserComb Lux 9 and HairMax LaserComb Professional 12

Indications for Use:

The HairMax LaserComb Advanced 7 is indicated to treat androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and Fitzpatrick Skin Types I to IV.

The HairMax LaserComb Lux 9 is indicated to treat androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and Fitzpatrick Skin Types I to IV.

The HairMax LaserComb Professional 12 is indicated to treat androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and Fitzpatrick Skin Types I to IV.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

NeRReOde
for mxm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103368

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.