The HairMax LaserComb Advanced 7 is indicated to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I to IV.

The HairMax LaserComb Pro 12 is indicated to treat Androgenetic Alopecia and promote hair growth in females with who have Ludwig-Savin Scale 1-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I to IV.

Device Description

Similar to the HairMax Lux 9 K110233, the modified HairMax Advanced 7 and Pro 12 consist of a hand-held low level laser device that emits laser light with the intention to promote 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.

AI/ML Overview

The provided text describes modifications to an existing device (HairMax Lux 9) and seeks substantial equivalence for the new devices (HairMax Advanced 7 and Pro 12). Therefore, it primarily focuses on comparing the new devices to the predicate rather than presenting a standalone study with acceptance criteria and performance metrics for the new devices based on a clinical trial.

However, based on the nonclinical testing section, we can infer that the acceptance criteria for the HairMax Advanced 7 and Pro 12 were primarily related to their compliance with design specifications and operational functionality, as they are considered substantially equivalent to the previously cleared HairMax Lux 9. The study proving this involved performance testing to confirm compliance to design specifications; all functions were verified to operate as designed.

Here's a breakdown of the information that can be extracted or reasonably inferred from the provided text, while also noting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Compliance to design specifications	All functions were verified to operate as designed.
No alteration in device safety (compared to predicate)	Modifications do not alter the safety of the device.
Same intended use as predicate	Has the same indicated use (androgenetic alopecia, hair growth in females Ludwig-Savin Scale I-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I to IV).
Same technological characteristics as predicate (e.g., laser modules, hair parting, wavelength, power)	Uses the exact same laser modules and hair parting teeth mechanism. Same laser power, wavelength, laser delivery method, comb component, instructions for use, and audible timer. (Differences in quantity of laser modules compensated by treatment time adjustments).
Substantial equivalence to predicate HairMax Lux 9	The Advanced 7 and Pro 12 are as safe and effective as the predicate device, HairMax Lux 9.

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

Sample Size for Test Set: Not mentioned. The testing described is "nonclinical testing" related to design specifications and functionality, not a clinical trial on human subjects.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned. Given it's nonclinical testing, this information would likely refer to laboratory or manufacturing test data, not patient data.

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

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Adjudication Method: Not mentioned. This type of method is typically associated with expert review of clinical data, which is not described here for the "test set" in question (which refers to nonclinical performance).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a low-level laser device for hair growth, not an AI-assisted diagnostic or imaging device.

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

Standalone Performance: Not applicable. This device is a hardware device (laser comb), not an algorithm or software. Its performance is inherent in its physical operation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: For the nonclinical testing described, the "ground truth" would be the design specifications and operational requirements of the device. The testing verified that the devices operated as designed and met these predefined technical criteria. The "ground truth" for the intended use (promoting hair growth) would have been established by studies on the predicate device (HairMax Lux 9), which is not detailed in this document.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that uses training sets.

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device.

Summary of what the document indicates for the new devices:

The document primarily focuses on demonstrating that the HairMax Advanced 7 and Pro 12 are substantially equivalent to the predicate device, HairMax Lux 9 (cleared under K110233). This substantial equivalence is based on:

Identical intended use and indications for use.
Identical core technological characteristics (same laser modules, hair parting teeth, operating principle, basic design, physical properties, materials, laser power, wavelength, delivery method, instructions for use, audible timer).
The only difference being the quantity of laser modules, with treatment time adjusted to compensate.
Nonclinical testing confirmed the new devices complied with design specifications and operated as designed, and that these modifications did not alter device safety.

The explicit detailed acceptance criteria and a human-results clinical study are not provided for the new devices in this document, as the submission relies on the established safety and efficacy of the predicate device.

Summary

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SEP 2 6 2011

6. 510(k) Summary

The following information is provided as required by 21 CFR § 807.87 for Lexington International, LLC HairMax LaserComb Lux 9 510(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.

Lexington International, LLC Sponsor: 777 Yamato Rd. Suite 105 Boca Raton, FL 33431 (561) 417-0200 research@hairmax.com Establishment Registration Number: 3006182775
Olsson Frank Weeda Contact: C/O Casper E Uldriks Esq. 1400 Sixteenth Street, NW Washington DC 20036

August 30, 2011 Date:

Proprietary Name: HairMax LaserComb

Common or Usual Name: Lamp, nonheating, for promotion of hair growth.

Product Code: OAP

Classification Name: 21 CFR 890.5500 Infrared lamp

Predicate Device: HairMax Lux 9 K110233

Device Description:

Intended Use / Indications for Use

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Technological Characteristics

The modifications to the HairMax Lux 9 since its previous clearance in K110233 do not alter the safety of the device. The predicate device contains 9 laser modules. The modified devices use the exact same laser modules and hair parting teeth mechanism. The difference in the predicate versus modified device is the quantity of the laser modules. The Advanced 7 contains 7 laser modules and the Pro 12 contains 12 laser modules. Adjustments in treatment time compensate for the different number of laser modules.

Nonclinical Testing

Based on the Risk Analysis, the verification and validation tests that were performed and the acceptance criteria applied for each are listed in Section 10. The HairMax Advanced 7 and Pro 12 were subject to the same preclinical requirements as the predicate device. Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed.

Substantial Equivalence

The Advanced 7 and Pro 12 are as safe and effective as the predicate device, HairMax Lux 9. The subject devices have the same intended use of affecting hair growth as the predicate device. The subject devices have indications, i.e., treating androgenetic alopecia, and the same specific indication of promoting hair growth in females, who have Ludwig-Savin Scale I-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I to IV, as the predicate device.

The Advanced 7 and Pro 12 are identical in technological characteristics as the device cleared in K110233, including its laser power, wavelength, laser delivery method, its comb component, its instructions for use and its audible timer. The changes in the number of laser modules does not change the safety or effectiveness.

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Conclusion:

The Advanced 7 and Pro 12 have the following similarities to the HairMax Lux 9:

has the same indicated use, ●
same identical laser modules .
. same hair parting teeth
uses the same operating principle .
incorporates the same basic device design and physical properties .
incorporates the same materials .

Therefore the modification to the Lux 9 can be found substantially equivalent to the HairMax LaserComb cleared in K110233.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized emblem featuring three abstract shapes, possibly representing human figures or elements of health and well-being. The emblem is simple and modern in design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-Ci609 Silver Spring, MD 20993-0002

Lexington International, LLC % Olsson Frank Weeda Casper E Uldriks, Esq. 1400 16th Street Northwest. Suite 400 Washington, District of Columbia 20036

SEP 26. 2011

Re: K112524

Trade/Device Name: HairMax Advanced 7, HairMax Professional 12 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Il Product Code: OAP Dated: September 16, 2011 Received: September 19, 2011

Dear Mr. Uldriks:

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

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Page 2 - Casper E Uldriks, Esq.

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Reportal?roblem/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 Small Manufacturers, International and Consumer Assistance 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.

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

Sincerely yours,

for

Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5. Indications for Use

510(k) Number (if known): K (12524

Device Name: HairMax Advanced 7, HairMax Professional 12

Indications for Use:

The HairMax LaserComb Advanced 7 is indicated to treat androgenetic alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal and Fitzpatrick Skin Types I to IV.

The HairMax LaserComb Professional 12 is indicated to treat androgenetic alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal 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)

Neil RP Ogle for nuxen

(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112524

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.