SUNETICS CLINICAL BIO-STIMULATION LASER

K132646 · Sunetics International Marketing Group, LLC · OAP · Dec 20, 2013 · Physical Medicine

Device Facts

• Record ID: K132646
• Device Name: SUNETICS CLINICAL BIO-STIMULATION LASER
• Applicant: Sunetics International Marketing Group, LLC
• Product Code: OAP · Physical Medicine
• Decision Date: Dec 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Sunetics Clinical Laser is indicated to treat Androgenetic Alpopecia (Hair Loss) and to promote hair growth in Males who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV. The Sunetics Clinical Laser is indicated to treat Androgenetic Alpopecia (Hair Loss) and to promote hair growth in Females who have Ludwig (Savin) 1-4, 11-1, 11-2, or frontal patterns of hair loss and Fitzpatrick Skin Types I to IV.

Device Story

Stationary, non-invasive low-level laser device; treats Androgenetic Alopecia via bio-stimulation. Input: electrical power. Transformation: utilizes laser modules to emit 650 nm wavelength red laser light in a continuous wave (CW) mode; output power <5 mW. Output: coherent laser light dispersed from an 'Open Panel' hood array covering the entire scalp. Used in clinical settings; operated by healthcare personnel. Device rests slightly above patient's head to deliver timed, equally distributed laser energy. Output provides therapeutic bio-stimulation to promote hair growth. Benefits patient by non-invasively addressing hair loss.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing verified compliance with design specifications, including laser wavelength, output power, and energy delivery. Electrical safety and EMC testing conducted per IEC 60601-1 and 60601-1-2; laser safety certified to Class 3R per IEC 60825-1.

Technological Characteristics

Stationary, non-invasive low-level laser device. Emits 650 nm red laser light; <5 mW output power; continuous wave (CW) beam. Features 'Open Panel' hood array for scalp coverage. Energy source: electrical. Safety standards: IEC 60601-1 (electrical), IEC 60601-1-2 (EMC), IEC 60825-1 (Class 3R laser).

Indications for Use

Indicated for treatment of Androgenetic Alopecia and promotion of hair growth in males (Norwood Hamilton IIa-V) and females (Ludwig/Savin 1-4, II-1, II-2, or frontal patterns) with Fitzpatrick Skin Types I-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

• MEP-90 Hair Growth Stimulation System - Midwest RF LLC - K091496
• i grow II Hair Growth System - Apira Science Inc - K122248
• Theradome LH80 PRO Laser Helmet - Theradome Inc - K122950
• Theradome Laser Helmet LH80 PRO - Theradome Inc - K113097

Submission Summary (Full Text)

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# DEC 2 0 2013

### ATTACHMENT 2

## 510(k) SUMMARY

| 510(k) Owner: | Sunetics International Marketing Group LLC<br>892 Steger Towne Rd Suite # 44<br>Rockwall, TX 75032 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | John Carullo |
| Phone: | 214-683-0724 |
| Date Summary<br>Prepared: | August 9, 2013 |
| Device: | |
| Trade Name: | Sunetics Clinical Laser "G" or "W2326" |
| Common/Classification Name: | Light Therapy Hair System<br>Product Code OAP; NHN<br>21 C.F.R. § 890.5500 (Infrared lamp) |
| Classification: | Class II |
| Predicate<br>Devices: | MEP-90 Hair Growth Stimulation System - Midwest RF LLC - K091496<br>i grow II Hair Growth System - Apira Science Inc - K122248<br>Theradome LH80 PRO Laser Helmet - Theradome Inc - K122950<br>Theradome Laser Helmet LH80 PRO - Theradome Inc - K113097 |
| Device<br>Description: | The Sunetics Clinical Laser (model "G" & model "W2326") is a stationary,<br>non-invasive, low-level laser device intended to treat Androgenetic Alopecia<br>(Hair Loss) and to promote hair growth in both Males and Females. The<br>Sunetics Clinical Laser device provides distributed red laser light dispersing<br>from an "Open Panel" Hood utilizing laser modules with a 650 nm wavelength.<br><5 mW output power, producing a continuous wave "CW" output beam. The<br>"Open Panel" Hood is designed to maximize the delivery of the coherent laser<br>light to effectively cover the entire scalp of the user during treatment. |

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Sunetics International Marketing Group LLC

510(k) Submission Sunetics Clinical Laser

- The Sunetics Clinical Laser (model "G" & model "W2326") is indicated to Intended Use: treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in Males who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV and also in Females who have Ludwig (Savin) 1-4, II-1, 11-2, or frontal patterns of hair loss & Fitzpatrick Skin Types I to IV.
The Sunetics Clinical Laser (model "G" & model "W2326") is a stationary Technological device that produces red laser energy dispersed from an "Open Panel" Hood Characteristics: array as it rests slightly above a patient's head and creates a laser field that covers the patients entire scalp area. The device produces timed treatments of equally distributed laser energy to the full scalp area. The medically prescribed treatment received from the laser energy promotes hair growth in Males and Females and treats Androgenetic Alopecia (Hair Loss) by the therapeutic modality of bio-stimulation.

Biocompatibility Not applicable. Data:

The evaluation of the perfomance data presented confirms that the Sunetics Performance Clinical Laser (model "G" & model "W2326") has the same or similar laser Data: wavelength, output power, output beam, energy type, laser field, treament area and energy delivery as the FDA Cleared predicate devices.

> Testing to IEC 60601-1 and 60601-1-2 confirm the devices adherence to LVD electrical and EMC safetly requirements. Testing to IEC 60825-1 certifies the laser system to classifaction 3R, which is the same as the predicate devices.

> Performance Testing is conducted to confirm compliance to design specifications; all functions were verified to operate as designed. The Sunetics Clinical Laser met all acceptance criteria in the performance testing.

The Sunetics Clinical Laser (model "G" & model "W2326") is as safe and Conclusions: effective as the FDA Cleared predicate devices and is thefore Substantial Equivalent to the FDA Cleared predicate devices with respect to intended use, technological characteristics and safety characteristics.

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Image /page/2/Picture/0 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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

December 20, 2013

Re: K132646

Trade/Device Name: Sunetics Clinical Laser "G" or "W2326" Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP, NHN Dated: November 21, 2013 Received: November 25, 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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. John Carullo

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Joshua @ Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

K 132646 510(k) Number (if known):

Sunetics Clinical Laser ......... models: "G" & "W2326" Device Name:

Indications for Use: The Sunetics Clinical Laser is indicated to treat Androgenetic Alpopecia (Hair Loss) and to promote hair growth in Males who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV.

> The Sunetics Clinical Laser is indicated to treat Androgenetic Alpopecia (Hair Loss) and to promote hair growth in Females who have Ludwig (Savin) 1-4, 11-1, 11-2, or frontal patterns of hair loss and Fitzpatrick Skin Types I to IV.

Prescription Use _X_ AND/OR (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden -S 2013.12.20 15:34:52 -05'00'

(Division Sign-Off) for BSA

Division of Surgical Devices

510(k) Number__ K132646