HAIRMAX LASERCOMB

K093499 · Lexington International, LLC · OAP · Nov 23, 2009 · Physical Medicine

Device Facts

• Record ID: K093499
• Device Name: HAIRMAX LASERCOMB
• Applicant: Lexington International, LLC
• Product Code: OAP · Physical Medicine
• Decision Date: Nov 23, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The HairMax LaserComb is indicated to promote hair growth in males, 30-60 years of age with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and Fitzpatrick Skin Types I to IV.

Device Story

Hand-held low-level laser device; emits laser light to scalp to promote hair growth. Comb teeth part hair to ensure light reaches scalp. Operated by user at home. Modified version adds Lithium-ion battery power supply option to original wall-transformer-only design; includes cosmetic changes to housing color and dimensions. Device includes audible timer. User applies device to scalp; laser light exposure intended to stimulate hair follicles. Benefits include potential promotion of hair growth in specified male population.

Clinical Evidence

No new clinical data provided. Substantial equivalence based on identical technological characteristics and performance testing confirming compliance to design specifications.

Technological Characteristics

Low-level laser device; Class II infrared lamp (21 CFR 890.5500). Power source: wall transformer or Lithium-ion battery. Features comb teeth for scalp parting and audible timer. Plastic housing. No software-based algorithms.

Indications for Use

Indicated for males, 30-60 years old, with androgenetic alopecia (Norwood-Hamilton IIa-V) and Fitzpatrick Skin Types 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

• HairMax LaserComb (K060305)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Lexington International, LLC. The word "Lexington" is in a bold, sans-serif font, with a curved line above it. Below "Lexington" is the text "International, LLC" in a smaller font. To the right of the text is a star.

K093499

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

# 6. 510(k) Summary

Lexington International, LLC

HairMax LaserComb ver. 5.2

# NOV 2 3 2009

# Submitter's Contact Information

| Name: | David Michaels, Managing Director |
|---------------|-----------------------------------|
| Address: | Lexington International, LLC |
| | 777 Yamato Rd. Suite 105 |
| | Boca Raton, FL 33431 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| E-mail: | [e-mail] |
| Manufacturer: | Lexington International, LLC |

Establishment Registration Number: 3006182775

## Official Correspondent

| Name: | Cherita James, Regulatory Consultant |
|------------|--------------------------------------|
| Address: | M Squared Associates, Inc. |
| | 901 King Street, Suite 200 |
| | Alexandria, VA 22314 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| E-mail: | [e-mail] |

Trade Name: HairMax LaserComb Common or Usual Name: Lamp, nonheating, for promotion of hair growth. Product Code: OAP

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a logo for Lexington International, LLC. The word "Lexington" is in a bold, sans-serif font, with a horizontal line running through the middle of the word. Above the word "Lexington" is a curved line. Below the word "Lexington" is the text "International, LLC" in a smaller, sans-serif font. To the right of the word "Lexington" is a star.

ton International. LLC Yamato Road, Suite 105 Boca Raton, FL. 33431

Classification Name: 21 CFR 890.5500 Infrared lamp Predicate Device: HairMax LaserComb K060305

### November 9, 2009

### Device Description:

Similar to the HairMax LaserComb K060305, the modified HairMax LaserComb consists 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.

The predicate unit operates from solely on a class 2, UL and CUL rated wall The modified unit adds a Lithium ion battery power supply option. In transformer. addition, cosmetic changes are being made to the device color and exterior plastic housing. Changes do not alter form fit or function as compared to the predicate device.

#### Intended Use / Indications for Use

The HairMax LaserComb is indicated to promote hair growth in males, 30-60 years of age with androgenetic alopecia who have Norwood Hamilton Classification IIa -V patterns of hair loss and Fitzpatrick Skin Types I to IV.

#### Technological Characteristics

The modifications to the HairMax LaserComb since its previous clearance in K060305 include changes to available power supply, and consequently the device casing dimensions and color. These minor differences do not affect the safety or performance of the device and do not change the intended use of the HairMax LaserComb.

#### 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 modified HairMax LaserComb was subject to the same preclinical requirements as the

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for Lexington International, LLC. The word "Lexington" is in a bold, sans-serif font, with a line underneath it. Below that is the word "International, LLC" in a smaller, sans-serif font. There is a curved line above the word "Lexington" and a star to the right of the word.

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

predicate device. Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed.

## Substantial Equivalence

The modified HairMax LaserComb is as safe and effective as the predicate device. The modified device has the same intended use of affecting hair growth as the predicate device. The modified HairMax LaserComb has the same indications, i.e., treating androgenetic alopecia, and the same specific indication of promoting hair growth in males, 30-60 years of age with androgenetic alopecia who have Norwood-Hamilton Classifications of I to V patterns of hair loss and Fitzpatrick Skin types of I-IV as the predicate device.

The modified HairMax LaserComb is identical in technological characteristics as the device cleared in K060305, including its laser power, wavelength, laser delivery method, its comb component, its instructions for use and its audible timer. The cosmetic change to device color and dimensions of the exterior plastic housing and addition of a battery does not affect the HairMax LaserComb's fundamental scientific technology.

### Conclusion:

The modified HairMax LaserComb has the following similarities to the HairMax LaserComb:

- . has the same indicated use,
- uses the same operating principle, .
- incorporates the same basic device design and physical properties, .
- . incorporates the same materials.

Therefore the modification to the modified HairMax LaserComb can be found substantially equivalent to the HairMax LaserComb cleared in K060305.

{3}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Lexington International, LLC % M Squared Associates, Inc. Ms. Cherita James Regulatory Consultant 901 King Street, Suite 200 Alexandria, Virginia 22314

NOV 2 3 2009

Re: K093499

Trade/Device Name: HairMax LaserComb Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP, GEX Dated: November 10, 2009 Received: November 12, 2009

Dear Ms. James:

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 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

{4}------------------------------------------------

Page 2 - Ms. Cherita James

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/cdrh/mdr/ 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M Millerson

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

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Lexington International, LLC. The word "Lexington" is in a larger, bold font, with a line underneath it. Below that, the words "International, LLC" are in a smaller font. There is a curved line above the word "Lexington" and a star to the right of the logo.

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

# 5. Indications for Use

510(k) Number (if known): Ko 9 3 499

Device Name: HairMax LaserComb

Indications for Use:

The HairMax LaserComb is indicated to promote hair growth in males, 30-60 years of age with androgenetic alopecia 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 _________________________________________________________________________________________________________________________________________________________ (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 N. Mulhausen

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093499