HairMax LaserComb, HairMax LaserComb

K142573 · Lexington International, LLC · OAP · Dec 1, 2014 · Physical Medicine

Device Facts

• Record ID: K142573
• Device Name: HairMax LaserComb, HairMax LaserComb
• Applicant: Lexington International, LLC
• Product Code: OAP · Physical Medicine
• Decision Date: Dec 1, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 1-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.

Device Story

HairMax LaserComb 41 and 82 are low-level laser devices for home use to treat androgenetic alopecia. Devices feature hair-parting teeth to ensure laser light reaches the scalp. HMLC 82 emits 82 laser beams; HMLC 41 emits 41 beams; both at 655 nm wavelength. User places device on scalp sections; device uses vibration to signal when to move to next position. Proximity sensor prevents laser activation unless in contact with scalp. Internal lithium polymer battery powers device. Lasers automatically turn off after treatment duration. Output is intended to promote hair growth. Healthcare providers do not operate; patient self-use.

Clinical Evidence

Bench testing only. Laser safety testing per IEC60825-1:2007 confirmed Class 3R operation. Laser output parameters and dose rates were verified against predicate devices using calibrated equipment, confirming output levels are substantially equivalent within +/-10% tolerance.

Technological Characteristics

Low-level laser device; 655 nm (+/- 10 nm) wavelength; Class 3R laser. Features hair-parting teeth, proximity sensor, and internal rechargeable lithium polymer battery. Powered by 6VDC/1000mA wall transformer. Software-controlled treatment timing and vibration alerts. Designed for hands-free scalp contact.

Indications for Use

Indicated for males with Norwood Hamilton Classifications IIa to V and females with Ludwig (Savin) Scale I-4, II-1, II-2, or frontal patterns of Androgenetic alopecia, with Fitzpatrick Skin Types I to 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 Lux 9 (K110233)
• HairMax LaserComb Lux 9 (K103368)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, resembling a bird-like shape.

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

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

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 [phone] or [phone] 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 [phone] or [phone] 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

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

# 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 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 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) | |
|-------------------------------------------------|---------------------------------------------------------------|
| | <div style="display: flex;"> <div> </div> <div> </div> </div> |

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

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# 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 [e-mail] Tel: [phone] Fax: [phone]

- 2. Establishment Registration Number: 3006182775
- 3. Device Name:

| a. Trade Name: | HairMax LaserComb 41<br>HairMax 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

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

#### 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

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.

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

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.

- 7. 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.

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.

- 8. 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.

- 9. Performance

{6}------------------------------------------------

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.