HairMax Laser
Device Facts
| Record ID | K180885 |
|---|---|
| Device Name | HairMax Laser |
| Applicant | Lexington International, LLC |
| Product Code | OAP · Physical Medicine |
| Decision Date | Jun 20, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5500 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The HairMax Laser 272, 202 and 80 are indicated to promote hair growth in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa - V, females who have Ludwig-Savin Classifications of I - II or Frontal and for both, Fitzpatrick Skin Phototypes I to IV.
Device Story
HairMax Laser 272, 202, and 80 are helmet-style devices designed for home use to promote hair growth via low-level laser therapy (LLLT). Devices consist of an outer cap helmet and protective inner liner containing 272, 202, or 80 diode lasers, respectively. Powered by a lithium-ion battery pack with an embedded controller chip. Operation is passive and hands-free; user wears device for 30 minutes every other day for 16 weeks. Radiant energy (650±5 nm) is delivered to the upper 1/3 of the head. No clinical data provided; substantial equivalence based on identical design, optical/mechanical function, and treatment protocol to predicate devices. Intended for OTC use by patients to manage androgenetic alopecia.
Clinical Evidence
No clinical performance data produced. Substantial equivalence established via technical comparison to identical predicate devices. OTC usability study conducted with 40 subjects (male and female) demonstrated a 90% pass rate for self-selection, assembly, and comprehension of hazards/maintenance, exceeding the 80% success threshold.
Technological Characteristics
Helmet-style LLLT device; 80, 202, or 272 diode lasers (Class 3R); 650±5 nm wavelength. Powered by lithium-ion battery with embedded controller chip. Materials: outer cap helmet, protective inner liner. Standards: IEC 60825-1 (laser safety), IEC 60601-1-2 (EMC).
Indications for Use
Indicated for males with androgenetic alopecia (Norwood-Hamilton IIa-V) and females with androgenetic alopecia (Ludwig-Savin I-II or Frontal) with Fitzpatrick Skin Phototypes I-IV to promote hair growth.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
Reference Devices
- Illumiflow Laser Cap
Submission Summary (Full Text)
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June 20, 2018
Lexington International, LLC % Raymond Blanche Consultant NST Consulting, LLC 641 Shunpike Road, Suite 311 Chatham, New Jersey 07928
Re: K180885
Trade/Device Name: HairMax Laser Model 272, Model 202, and Model 80 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: February 19, 2018 Received: April 4, 2018
Dear Raymond Blanche:
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, 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 of medical device-related adverse events) (21 CFR 803); good
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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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Jennifer R. Stevenson -53
For 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) K180885
Device Name HairMax Laser Laser 272, 202, and 80
#### Indications for Use (Describe)
The HairMax Laser 272, 202 and 80 are indicated to promote hair growth in males with androgentic alopecia who have Norwood-Hamilton Classifications of IIa - V, or females with androgenetic alopecia who have Ludwig-Savin Classifications I - II or Frontal and for both with Fitzpatrick Skin Phototypes I- IV.
Type of Use (Select one or both, as applicable)
J Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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## 510(k) Summary
## Revised June 19, 2018
# Lexington International, LLC
## Submitter's Contact Information
| Name: | Raymond R. Blanche |
|--------------------------|--------------------------------------------------------------------------|
| Address | NST Consulting, LLC<br>641 Shunpike Road, Suite 311<br>Chatham, NJ 07928 |
| Telephone:<br>Facsimile: | (973) 539-7444<br>(973) 539-7445 |
## Name of Device and Name/Address of Sponsor
| Trade Name: | HairMax Laser 272, 202 and 80 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Sponsor Contact<br>Information: | David Michaels<br>Lexington International, LLC<br>1040 Holland Drive<br>Boca Raton, Florida 33487<br>Telephone: 561-417-0200 |
| Common or Usual Name: | Lamp, non-heating, for promotion of hair growth |
| Classification Name: | Infrared lamp per 21 CFR 890.5500 |
- Classification Code: OAP (Laser, comb, hair)
# Predicate Devices:
| Device Trade Name | Manufacturer |
|-------------------------|-----------------------------------|
| Diode Laser Cap K173678 | Cosmo Far East Technology Limited |
| Capillus 202 K163170 | Capillus, LLC |
| Lasercap 80 K161875 | Transdermal Cap, Inc. |
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#### Reference Devices:
Illumiflow Laser Cap
Cosmo Far East Technology Limited
Date Prepared: February 19, 2018
### Intended Use / Indications for Use
The HairMax Laser 272, 202 and 80 are indicated to promote hair growth in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa - V, females who have Ludwig-Savin Classifications of I - II or Frontal and for both, Fitzpatrick Skin Phototypes I to IV.
### Technological Characteristics
The HairMax Laser 272, 202 or 80 each contain the listed number of diode lasers configured within an outer cap helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head i.e., the area commonly covered with stylized hair. The HairMax Laser 272, 202 and 80 are powered by a lithium-ion battery pack that contains an embedded controller chip. In all other area of design, manufacturing, and aesthetic appearance, the devices are identical.
### Performance Data:
No clinical performance data was produced for this submission because the HairMax Laser 272, 202 and 80 are the same device as the predicate, the Diode Laser, cleared under K173678, the Capillus 202, cleared under K163170 and the Lasercap 80, cleared under K161875. All proposed devices and predicate devices are IDENTICAL and the same devices offered for PRIVATE LABEL by the manufacturer. They are the same device in optical, electronic, mechanical function and aesthetic appearance, as well as the same recommended clinical treatment regime. It is essential to understand that this class of device is manufactured by many different manufacturers, all using the same parts supplied by the same OEM suppliers. Hence, there are virtually no differences between the devices.
#### Substantial Equivalence
Both the HairMax Laser 272 and the Diode laser 272 use red light diode Lasers, classified as class IIIa/3R laser systems by the IEC standard for allowable emission levels, which is a recognized standard by the FDA as well, and the adverse event
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profile is the same. The sponsor believes that there is no difference in the physical appearance or in the method of delivering the radiant energy of the two systems and therefore, there are no variations in the therapeutic value or safety profile.
For these reasons, the HairMax Laser 272 overwhelmingly satisfies the FDA's substantial equivalence with respect to intended use, technological and design characteristics.
The HairMax Laser 202 and 80 are prospective devices that will be manufactured by an ISO 13485 compliant contract manufacturer, on the same platform as the Hairmax Laser 272. There are no safety concerns raised by this process of manufacturing because the model 272 contains the largest number of laser diodes, obviating the requirement for electronic heat analysis for the lesser diode laser models, the 202 and 80.
## Treatment Protocol
The HairMax Models 272, 202 and 80 the identified predicates, possess the same treatment regime of 30 minutes, every other day, on non-consecutive days, for the initial treatment regime of 16 weeks. .
The following Comparison Chart in support of substantial equivalence is provided:
| HairMax Laser 272, 202 and 80 | Diode Laser 272 | Capillus 202 | Lasercap 80 |
|---------------------------------------------------------------------------------------------|-----------------|--------------|-----------------|
| LLLT Device Type | Laser diode | Laser Diode | Laser Diode |
| Use Application | OTC | OTC | Rx |
| Intended Use - Androgenetic Alopecia | Yes | Yes | Yes |
| Contain Laser Diodes-Class 3R | Yes 272 | Yes 202 | Yes 80 |
| Helmet Design | Yes | Yes | Yes |
| $650\pm5$ NMS. | Yes | Yes | Yes |
| Marketing Clearance -Females & Males, OTC | Yes | Yes | Females Only Rx |
| Passive Use-Hands Free | Yes | Yes | Yes |
| OAP Classification | Yes | Yes | Yes |
| Classification Name -Infrared Lamp | Yes | Yes | Yes |
| Common Usage Name - Lamp, Non-Heating | Yes | Yes | Yes |
| General & Plastic Surgery Committee | Yes | Yes | Yes |
| Skin Phototypes - I- IV | Yes | Yes | Yes |
| Hamilton-Norwood IIa-V Hair Loss Classification | Yes | Yes | Yes |
| Ludwig-Savin I – II Hair Loss Classification | Yes | Yes | Yes |
| Efficacy Rates - High Compared to Placebo<br>Identical | Yes | Yes | Yes |
| Treatment- 16 weeks, for 30 minute treatment times three times a week<br>on alternate days. | Yes | Yes | Yes |
| Device Class II | Yes | Yes | Yes |
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The data presented in the Comparison Chart, demonstrates that all three HairMax models 272 devices are identical and equivalent, PRIVATE LABEL devices from the same manufacturer are identical and equivalent, PRIVATE LABEL devices. The Models 202 and 80 will be manufactured on the same platform by the same manufacturer as the 272.
Based on this comparison and determination, the sponsor requests the FDA to clear the device via the 510(k) notice.
## Over - The - Counter Testing Program
To test volunteer subjects for the suitability of the HairMax Laser 272, 202 and 80, 40 subjects were asked twenty-six questions, after being provided a standard retail package and a full owner's manual. The test subjects was given as long as they required to read and understand the product packaging and manual. No assistance was provided to them and they were not permitted to ask any questions of the interviewer. The interviewer then conducted the interview and filled in the responses from the subjects. The subjects were required to answer all questions correctly to be counted as PASS for the correct Self Selection or, to have made the correct decision to purchase the product or not; to assemble and use the product correctly and comprehend the hazards and maintenance procedures for the device. These decisions would be based upon their understanding of the Intended Use of the product and the manual.
If the questions were answered correctly, they were given a P for PASS. If any questions were answered incorrectly, they were given an F for FAIL. The number of subjects required to answer all questions correctly is 32 out of 40, for an 80% success rate.
The results of the Over-the-Counter testing demonstrate that the HairMax Laser 272, 202 and 80 comply with the requirements the FDA determined to be applicable. The test revealed an overall 90% pass rate for the subject group of 40 male and female participants. The testing further demonstrates that age, education, socioeconomic group, race or medical hair loss status are not variants that prevent proper self-selection, usability and comprehension of hazards and maintenance procedures for the average consumer to successfully navigate the purchasing and use process of the HairMax Laser 272, 202 and 80.
Based on this data, the sponsor believes that the Hairmax Laser 272, 202 and 80 for male and female users have met the requirements for OTC sale.
## Electrical Safety and Electromagnetic Compatibility Testing Performance
The HairMax Laser 272, 202 and 80 was evaluated for conformance to recognized international standards. The following is a list of these evaluations and tests that were found to be in conformance:
- 1. IEC 60825-1 Edition 2.0 2007-03 Safety of Laser Products Part 1: Equipment Classification and Requirements.
- 2. IEC 60601-1-2 Edition 3.0 2007-03 Medical Electrical Equipment Part 1-2 General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Part 1: Requirements and Tests.
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## Conclusion
Based on the technical comparisons between the HairMax 272, 202 and 80 and the identified predicates it can be concluded that the HairMax Models are identical to the predicate devices in technical specifications. Since the Hairmax Models are built using the identical platform with the only difference between models being the number of didoes, it can be concluded that all of the HairMax models are equally safe. Therefore,, it can be determined that the HairMax Model 272, 202 and 80 are Substantially Equivalent to the identified predicates.
