LASERBRUSH

K121920 · Sunetics International Marketing Group, LLC · OAP · Jun 27, 2013 · Physical Medicine

Device Facts

• Record ID: K121920
• Device Name: LASERBRUSH
• Applicant: Sunetics International Marketing Group, LLC
• Product Code: OAP · Physical Medicine
• Decision Date: Jun 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Sunetics LaserBrush is indicated to treat Androgenetic Alopecia, promote hair growth and prevent further hair loss in males who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV & also in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss & Fitzpatrick Skin Types I to IV.

Device Story

Handheld low-level laser device; utilizes 7, 9, or 12 collimated 650 nm laser modules (<5 mW); integrated brush bristles part hair to ensure scalp exposure; intended for home use by patients; promotes hair growth and prevents hair loss in Androgenetic Alopecia patients; provides distributed laser light to scalp.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing comparing laser wavelength, average/peak power levels, laser treatment field, and energy delivery to the predicate device.

Technological Characteristics

Handheld device; 650 nm laser modules (<5 mW); 7, 9, or 12 module configurations; integrated brush bristles for scalp parting; battery/power supply; non-invasive; no software or algorithmic components.

Indications for Use

Indicated for males (Norwood Hamilton IIa-V) and females (Ludwig/Savin I-4, II-1, II-2, or frontal patterns) with Androgenetic Alopecia and Fitzpatrick Skin Types I-IV to promote hair growth and prevent further hair loss.

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 LaserCombs - models: Advanced 7, Lux 9, Professional 12 (K110233, K103368, K112524)

Submission Summary (Full Text)

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K121920

Sunetics International Marketing Group LLC

510(k) Submission Sunetics LaserBrush

## ATTACHMENT 2

# 510(k) SUMMARY

JUN 2 7 2013

| 510(k) Owner: | Sunetics International Marketing Group LLC<br>892 Steger Towne Rd Suite # 44<br>Rockwall, TX 75032<br>Contact:<br>John Carullo<br>Phone:<br>214-683-0724 | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Date Summary<br>Prepared: | June 21, 2012 | |
| Device: | Trade Name: | Sunetics LaserBrush |
| | Common/Classification Name: | Laser, Comb, Hair<br>Product Code OAP |
| | | 21 C.F.R. § 890.5500 (Infrared lamp) |
| | Classification: | Class II |
| Predicate<br>Device: | HairMax LaserCombs - models: Advanced 7, Lux 9, Professional 12<br>Lexington International, LLC<br>K110233, K103368, Κ112524 | |
| Device<br>Description: | The Sunetics LaserBrush consists of a handheld low-level laser device<br>intended to promote hair growth. Depending upon the Sunetics LaserBrush<br>model, the device provides distributed laser light using seven (7), nine (9), or<br>twelve (12), collimated, 650 nm, <5 mW laser modules, while brush bristles<br>simultaneously part the user's hair to ensure that the laser light reaches the<br>user's scalp. | |
| Intended Use: | The Sunetics LaserBrush is indicated to treat Androgenetic Alopecia,<br>promote hair growth and prevent further hair loss in males who have<br>Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to<br>IV & also in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal<br>patterns of hair loss & Fitzpatrick Skin Types I to IV. | |
| Technological<br>Characteristics: | The Sunetics LaserBrush has the same intended power, wavelength, energy<br>source, laser beam pattern, laser treatment field, consumer usage focal point,<br>energy delivery, power supply, treatment time, indication for use, and target<br>population as the Hairmax LaserComb.<br>Not applicable. | |
| Biocompatibility<br>Data: | | |
| Performance<br>Data: | The laser wayeth length, average and peak power levels, laser treatment field<br>and energy delivery of the Sunetics LaserBrush and the Lexington Hairmax<br>LaserComb were substantially equivalent. | |
| Conclusions: | The performance data discussed above demonstrate that the Sunetics<br>LaserBrush device is as safe and effective as the predicate device. | |

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Sunetics International Marketing Group, LLC % Mr. John Carullo 892 Steger Towne Road, Suite 44 Rockwall, Texas 75032

Re: K121920

Trade/Device Name: Sunetics LaserBrush Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP Dated: June 05, 2013 Received: June 11, 2013

June 27, 2013

Dear Mr. Carullo:

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 that I DA has made a coulations 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

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Page 2 - Mr. John Carullo

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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

FOR

Peter D. Rumm -S

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

Enclosure

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Sunetics International Marketing Group LLC

510(k) Submission Sunetics LaserBrush

### ATTACHMENT 1

#### Indications for Use

510(k) Number (if known):

. K121920

Device Name:

Sunetics LaserBrush models: LHB 7, LHB 9, LHB 12

Indications for Use:

The Sunetics LaserBrush is indicated to treat Androgenetic Alpopecia and promote hair growth in males who have Norwood Hamilton Classifications of Ila to V and Fitzpatrick Skin Types I to IV.

The Sunetics LaserBrush is indicated to treat Androgenetic Alpopecia and promote hair growth in females who have Ludwig (Savin) I-4, 11-1, II-2, or frontal 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 X (21 CFR801 Subpart C)

PLEASE DO NOT WRITE BELOW TIDS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden Nell R Ogden
2013.06.24 17:36:30 -04'00'

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number K121920

June 28, 2012