The HairMax LaserComb 41 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 treat Androgenetic alopecia and, promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.

The HairMax LaserComb 82 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 treat Androgenetic alopecia and, promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.

Device Description

The HairMax LaserComb 41 (HMLC 41) and HairMax LaserComb 82 (HMLC 82) are low-level laser devices that provide distributed laser light to the scalp while comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The HMLC 82 device emits 82 laser beams with wavelengths of 655 nm (+/- 10 nm), spaced at 7mm intervals and has a total laser module output within the limitation of a Class 3R laser. The HMLC 41 device emits 41 laser beams with wavelengths of 655 mm (+/- 10 nm), spaced at 7mm intervals and has a total laser module output within the limitation of a Class 3R laser. The laser diode modules used in the HMLC 41 & 82 are identical to those used in their predicate devices.

As with the predicate device, the HMLC 41 & 82's lasers are contained in between hair parting teeth that push the hair aside, allowing the optimum amount of laser energy to reach the scalp, as the user passes over the scalp. The hair parting teeth move the hair aside and allow an unobstructed path of laser energy to the scalp.

At the beginning of a treatment session, the device is placed in the first position on the scalp (the first 7.5cm scalp section, closest to the forehead) and will rest here for the intended treatment time. As with the predicate devices, the HMLC 41 & 82 will use a short vibration to advise the user it is time to move to the next scalp location. The HMLC 41 & 82 will maintain contact with the scalp allowing the hair parting teeth to part the hair as the user moves the device backwards, combing the hair, along the scalp to the second position. The teeth are necessary to part the hair and provide an unobstructed path for the laser light to reach the scalp. The device will remain in the second position until the vibration informs the user to move to the third position. Similar indication and movement will continue for three positions to cover the entire area of hair loss on the scalp. The lasers will automatically turn off after the intended treatment duration.

The units operate from an internal, rechargeable lithium polymer battery. The LiPoly battery is charged from a Class 2, UL, and CUL rated wall transformer at 6VDC and 1000mA. In the event of a power failure, the laser control circuitry is designed to disable the laser diodes until reactivated by the control switch. The devices include battery monitoring and charging circuitry which ensure the effective delivery of optimal laser energy output during the treatment time. The devices include a proximity sensor and will not allow the lasers to be turned on unless in contact with the scalp.

AI/ML Overview

The provided text describes the HairMax LaserComb 41 and HairMax LaserComb 82 devices and their substantial equivalence to previously cleared predicate devices (HairMax LaserComb Lux 9, K110233 and K103368). The submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials for safety and effectiveness from scratch. Therefore, the information provided focuses on demonstrating that the new devices are as safe and effective as the predicate.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" for a new study are not presented in the typical sense of a clinical trial with primary and secondary endpoints. Instead, the performance is evaluated against the predicate device’s established safety and efficacy. The criteria primarily relate to maintaining the same technological characteristics and output as the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance
Safety:
- Laser safety (Class 3R operation)	- Confirmed per IEC60825-1:2007, Condition 1 and Condition 2.
- Electrical safety (e.g., battery, charger)	- Internal, rechargeable lithium polymer battery. Charged by Class 2, UL, CUL rated wall transformer (6VDC, 1000mA). Battery monitoring and charging circuitry ensure effective laser energy delivery.
- Accidental laser activation prevention	- Laser control circuitry disables diodes on power failure. Proximity sensor prevents laser activation unless in contact with the scalp.
Effectiveness/Performance:
- Laser output parameters and dose rate	- Verified against the predicate device using Ophir 7Z01560, Serial # 544640 (calibrated April 2014). Laser output levels were substantially the same as the predicate (within +/-10% tolerance). HMLC 41 & 82 use identical laser modules as the predicate, confirmed by module specifications and Certificate of Compliance (wavelength, divergence, power).
- Hair growth promotion (implied from predicate equivalence)	- "The results of the testing demonstrate that the modified devices (HMLC 41 & 82) operated as intended and are as safe and effective as the predicate device." The predicate device was cleared for treating Androgenetic alopecia and promoting hair growth.
- Intended use/indications	- Same as for the HairMax LaserComb Lux 9 (HMLC Lux 9) cleared pursuant to K103368 and K110233. (Specifically: treat Androgenetic alopecia and promote hair growth in males (Norwood Hamilton Classifications IIa to V) and females (Ludwig (Savin) Scale I-4, II-1, II-2, or frontal), both with Fitzpatrick Skin Types I to IV.)

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

The provided document describes bench testing to demonstrate performance and safety. It does not mention a clinical "test set" in the sense of human subjects with a specified sample size. The "data provenance" is from laboratory measurements and comparisons to the predicate device's established characteristics. There is no indication of country of origin for a clinical data set or whether it’s retrospective or prospective, as no new clinical study (involving human subjects) is described for this submission.

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

Not applicable for this submission. The ground truth for proving substantial equivalence here relies on bench test measurements against engineering specifications and comparison to a predicate device, rather than expert clinical consensus on a test set.

4. Adjudication Method for the Test Set

Not applicable. There is no human-adjudicated "test set" in the context of this 510(k) submission.

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

No MRMC comparative effectiveness study is mentioned. This submission focuses on demonstrating substantial equivalence through technological comparison and bench testing, not through new clinical trials with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is not an algorithm; it is a physical medical device. Therefore, a standalone algorithm performance study is not applicable. The device's "standalone" performance relates to its physical operation and outputs as measured in bench testing.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

Bench test measurements: Laser output parameters, dose rate, electrical characteristics.
Engineering specifications: Conformance to IEC60825-1:2007 for laser safety, and internal product specifications for laser modules (wavelength, divergence, power levels).
Regulatory precedent: The safety and effectiveness data of the legally marketed predicate devices (HairMax LaserComb Lux 9, K110233 and K103368) forms the foundational "ground truth" that the new devices are compared against for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This document describes a 510(k) submission based on substantial equivalence, not the development of a machine learning algorithm that requires a "training set."

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

Not applicable, as there is no "training set" in this context.

Summary

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

December 1, 2014

Lexington International, LLC % Mr. Evan P. Phelps OFW Law 600 New Hampshire Avenue, NW, Suite 500 Washington, District of Columbia 20037

Re: K142573

Trade/Device Name: HairMax LaserComb 82 and HairMax LaserComb 41 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP Dated: September 12, 2014 Received: September 15, 2014

Dear Mr. Phelps:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142573

Device Name

Device Name: HairMax LaserComb 82 and HairMax LaserComb 41

Indications for Use (Describe)

The HairMax LaserComb 82 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 treat Androgenetic alopecia and, promote hair growth in females who have Ludwig (Savin) Scale 1-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.

Type of Use (Select one or both, as applicable)

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

"510(k) Summary" As required by section 807.92(c) For HairMax LaserComb 41 and HairMax LaserComb 82

September 11, 2014

1. Company Name and Address
- a. Sponsor/Manufacturer

Lexington International, LLC 777 Yamato Road Suite 105 Boca Raton, FL 33431

b. Consultant/Contact
Evan P. Phelps OFW Law 600 New Hampshire Ave, Ste. 500 Washington D.C. 20037 ephelps@ofwlaw.com Tel: (202) 789-1212 Fax: (202) 234-3550
1. Establishment Registration Number: 3006182775
1. Device Name:

a. Trade Name:	HairMax LaserComb 41HairMax LaserComb 82
b. Common/Usual Name:	Lamp, Non-Heating, for Promotion of Hair Growth
c. Classification Name:	Comb, Laser, Hair

4. Device Classification:

21 C.F.R. § 890.5500 (Class II) a.
b. Product Code: OAP
c. Classification Panel: General & Plastic Surgery

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5. Legally Marketed Predicate Devices:

a. HairMax LaserComb Lux 9 i. 510(k) Owner: Lexington International, LLC ii. 510(k) Number: K110233 21 C.F.R. § 890.5500 (Class II) Product Code: OAP b. HairMax LaserComb Lux 9 i. 510(k) Owner: ii. 510(k) Number: K103368
Lexington International, LLC 21 C.F.R. § 890.5500 (Class II) Product Code: OAP

6. Device Description

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1. Intended Use
  The intended use of the HairMax LaserComb 41 and HairMax LaserComb 82 is the same as for the HairMax LaserComb Lux 9 (HMLC Lux 9) cleared pursuant to K103368 and K110233.

1. Technological Characteristics
  The HMLC 41 & 82 are versions of Lexington's previously cleared HMLC Lux 9 that has been modified as a result of customer feedback to provide hands-free operation for ease of use. To address this issue and reduce the overall effort required by users, Lexington sought to: 1) modify the shape of the device such that it can rest on the scalp (without the need for the user to hold it in place with their hand) while maintaining the device's hair-parting teeth feature; and 2) reduce treatment time by increasing the number of lasers providing treatment over a larger surface area while maintaining dosage rate. The implemented modifications included changes to:
Device configuration/dimensions to accommodate additional lasers and allow "handsfree" placement on the scalp;
Addition of a second identical battery
Conforming software changes reflecting reduced overall treatment time; and
. Addition of a proximity sensor for laser activation.

Otherwise, the modified devices have the same technological characteristics as their predicate to include operating principle, fundamental scientific technology, design, materials, and chemical composition.

1. Performance

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Evidence of safety and efficacy was obtained from bench testing to support the intended use of this device to include:

Laser Safety testing to confirm Class 3R operation per IEC60825-1:2007, Condition 1 and Condition 2
Laser output parameters and dose rate were verified against the predicate device using -Ophir 7Z01560, Serial # 544640 with a last calibration date April 2014. Laser output levels were substantially the same to the predicate within the accepted +/-10 tolerance range of the laser specifications.
HMLC 41 & 82 use identical laser modules as the Predicate Device. A review of the -Laser module specifications and Certificate of Compliance confirms wavelength, divergence and power levels to be identical.

The results of the testing demonstrate that the modified devices (HMLC 41 & 82) operated as intended and are as safe and effective as the predicate device.

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.