HAIRMAX LASERCOMB

K060305 · Lexington International, LLC · OAP · Jan 18, 2007 · Physical Medicine

Device Facts

• Record ID: K060305
• Device Name: HAIRMAX LASERCOMB
• Applicant: Lexington International, LLC
• Product Code: OAP · Physical Medicine
• Decision Date: Jan 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The LaserComb is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV.

Device Story

HairMax LaserComb is a hand-held, OTC low-level laser device for home use. It emits distributed red laser light to the scalp to promote hair growth. The device features integrated comb teeth that part the user's hair, ensuring laser light reaches the scalp surface. An audible timer emits a beep every four seconds to guide the user to move the device to a new scalp section. By delivering light directly to the scalp, the device aims to increase terminal hair density. Users operate the device independently; clinical benefits include improved hair regrowth and increased hair density compared to placebo.

Clinical Evidence

Multicenter, randomized, placebo-controlled trial (n=4 sites). Subjects used the LaserComb or sham device multiple times per week for 26 weeks. Results showed significantly greater increases in mean terminal hair density and better subjective assessments of overall hair regrowth in the LaserComb group compared to the placebo group. No serious adverse events reported; adverse event profiles were similar between groups.

Technological Characteristics

Hand-held low-level laser device. Emits red laser light. Features integrated comb teeth for scalp parting and an audible timer (4-second interval). Operates as an OTC device.

Indications for Use

Indicated for males with androgenetic alopecia, Norwood Hamilton Classifications IIa to V, and Fitzpatrick Skin Types I to IV.

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

• Robi Combi
• DermaLight
• Psoracomb
• Quantum WARP 10 Light Delivery System
• Lumiphase-R
• TerraQuant MQ2000 Laser Therapy Device
• MLT R694 Ruby Laser System
• L600 Hair Removal
• Violet Ray Device
• Vacuum Cap
• Raydo and Wonder Brush

Submission Summary (Full Text)

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# K 060305

# 510(k) SUMMARY

# Lexington International, LLC LaserComb

# Submitter's Contact Information

| Name: | David Michaels, Managing Director | JAN 1 8 2007 |
|--------------------------------------------|----------------------------------------------------------------------------------------------|--------------|
| Address: | Lexington International, LLC<br>2650 North Military Trail, Suite 360<br>Boca Raton, FL 33431 | |
| Telephone: | [phone] | |
| Facsimile: | [phone] | |
| Name of Device and Name/Address of Sponsor | | |

- Trade Name: HairMax LaserComb

| Sponsor Contact<br>Information: | David Michaels<br>Lexington International, LLC<br>2650 North Military Trail, Suite 360<br>Boca Raton, FL 33431 |
|---------------------------------|----------------------------------------------------------------------------------------------------------------|
|---------------------------------|----------------------------------------------------------------------------------------------------------------|

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

Classification Name: Infrared lamp per 21 CFR 890.5500

# Predicate Devices

Device Trade Name Robi Combi DermaLight Psoracomb Quantum WARP 10 Light Delivery System Lumiphase-R TerraQuant MQ2000 Laser Therapy Device MLT R694 Ruby Laser System L600 Hair Removal Violet Ray Device Vacuum Cap Raydo and Wonder Brush

# Manufacturer Epilady 2000, LLC Solitec GMBH Quantum Devices, Inc. Opusmed Inc. Escada International, Inc. Medical Laser Technologies Ltd. A&M Technology Manufacturer unknown Evans Dr. Scott

Date Prepared:

September 27, 2006

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06030)

# Intended Use / Indications for Use

The LaserComb is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV.

# Technological Characteristics

The LaserComb consists of a hand-held low level laser device that promotes 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. When in use, the device emits a beep every four seconds to notify the user to move the device to a new section of the scalp.

# Performance Data

A multicenter, randomized, placebo-controlled trial was conducted at four sites in the United States. Subjects received either the LaserComb or a sham device. Subjects were instructed to use the device times per week on nonconcurring days for a total of 26 weeks. Subjects in the LaserComb treatment group had significantly greater increases in mean terminal hair density than subjects in the placebo group. Subjects in the LaserComb group also had significantly better subjective assessments of overall hair regrowth than subjects in the placebo group. No subject experienced a serious adverse event and the adverse event profiles were similar between the two treatment groups. In all instances, the LaserComb functioned as intended and the hair regrowth observed was as expected.

## Substantial Equivalence

The LaserComb is as safe and effective as a combination of those predicate devices. The LaserComb has the same intended use of affecting hair growth as its preamendments hair growth predicate devices and its laser hair removal predicates. In addition, the LaserComb has the same general indications, i.e., treating baldness, and the same specific indication of promoting hair growth as its preamendments predicate devices. The LaserComb also has many of the same or similar technological characteristics as a combination of its predicate devices, including its red laser wavelength, its split beam laser delivery system, its comb component, and its audible timer. The technological differences between the LaserComb and its predicate devices. namely use of red laser to promote hair growth, do not raise new questions of safety or effectiveness for several reasons. First, the safety and effectiveness profile of that type of laser is well-established. Second, FDA's clearance of a red laser with virtually the same wavelength (for a cosmetic-type indication) confirms the favorable risk benefit ratio of red lasers, even when they are used for cosmetic-like indications. Finally, the clinical data summarized in the 510(k) notice confirms the safety and effectiveness of the LaserComb for OTC use in promoting hair growth in its intended patient population, despite those technological characteristics. For those reasons, the LaserComb satisfies FDA's substantial equivalence with respect to both the intended use and technological characteristics.

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060305

There are some technological differences between the LaserComb and its predicate devices. Namely, none of the predicate devices deliver laser light to the scalp to promote hair growth. For this reason, Lexington conducted a clinical study of the LaserComb to show that the device functions as intended for its proposed indication without serious side effects.

The clinical data demonstrates that the LaserComb is effective in promoting hair growth and does not present any safety issues. Therefore, the LaserComb satisfies FDA's substantial equivalence criteria. Thus, FDA should clear the device via the 510(k) notice containing clinical data.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized depiction of a caduceus, a symbol often associated with medicine and healthcare. The caduceus in the seal is a modern interpretation, representing health and well-being. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lexington International, LLC % King & Spaulding, LLP Mr. Edward M. Basile Senior Partner 1700 Pennsylvania Avenue, Northwest Washington, District of Columbia 20006-4706

Re: K060305

Trade/Device Name: HairMax LaserComb Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, Non-Heating for Hair Growth Regulatory Class: II Product Code: OAP Dated: September 29, 2006 Received: September 29, 2006

Dear Mr. Basile:

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.

JAN 1 8 2007

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 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 (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.

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Page 2 – Mr. Edward M. Basile

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, permits 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 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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Indications for Use

510(k) Number (if known): /< 060 30 30 30 30

Device Name: HairMax LaserComb

Indications for Use:

The LaserComb is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V 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)

Mark A. Millman

Vision Sign-Off) Division of General, Restorative and Neurological Devices

:(k) Number K06.0305

WDC_IMANAGE-805437 v1-11743.189001