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 Description

The Sunetics Clinical Laser (model "G" & model "W2326") is a stationary, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in both Males and Females. The Sunetics Clinical Laser device provides distributed red laser light dispersing from an "Open Panel" Hood utilizing laser modules with a 650 nm wavelength, <5 mW output power, producing a continuous wave "CW" output beam. The "Open Panel" Hood is designed to maximize the delivery of the coherent laser light to effectively cover the entire scalp of the user during treatment.

AI/ML Overview

The provided text describes the Sunetics Clinical Laser device and its 510(k) submission for market clearance. However, it does not contain information about a study that used a test set, ground truth established by experts, or statistical performance criteria for the device's efficacy in treating hair loss.

The document focuses on the device's technological characteristics, safety testing (electrical, EMC, laser classification), and its substantial equivalence to predicate devices based on these characteristics and intended use. Performance data is mentioned as confirming similar laser wavelength, output power, etc., but this refers to technical specifications, not clinical efficacy metrics.

Therefore, most of the requested information cannot be extracted from this document, as a clinical performance study as described in the prompt was not part of this 510(k) submission.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria Category	Acceptance Criteria (from document)	Reported Device Performance (from document)
Technological Performance	Safe and effective as predicate devices with respect to intended use, technological characteristics, and safety characteristics.	Evaluation of performance data confirms the device has the same or similar laser wavelength, output power, output beam, energy type, laser field, treatment area, and energy delivery as FDA Cleared predicate devices.
Electrical Safety	Adherence to LVD electrical safety requirements (IEC 60601-1).	Confirmed adherence to LVD electrical safety requirements.
EMC Safety	Adherence to EMC safety requirements (IEC 60601-1-2).	Confirmed adherence to EMC safety requirements.
Laser Classification	Certification to laser classification 3R (IEC 60825-1), same as predicate devices.	Certified to laser classification 3R, which is the same as the predicate devices.
Design Specifications	Compliance to design specifications; all functions verified to operate as designed.	Met all acceptance criteria in performance testing; all functions were verified to operate as designed.

2. Sample sized used for the test set and the data provenance:

Not applicable / Not provided. The submission focuses on device safety and technical equivalence, not a clinical efficacy study with a test set of patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. No clinical test set or ground truth on efficacy was established as part of this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable / Not provided. No clinical test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This document is for a laser therapy device, not an AI-assisted diagnostic tool requiring MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical therapy device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable / Not provided for clinical efficacy. The "performance data" mentioned relates to the device's technical specifications and electrical/laser safety, not clinical outcomes for hair growth. The ground truth for safety aspects would be compliance with international standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1).

8. The sample size for the training set:

Not applicable / Not provided. This device does not have a "training set" in the context of machine learning or clinical trials.

9. How the ground truth for the training set was established:

Not applicable / Not provided.

Summary

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DEC 2 0 2013

ATTACHMENT 2

510(k) SUMMARY

510(k) Owner:	Sunetics International Marketing Group LLC892 Steger Towne Rd Suite # 44Rockwall, TX 75032
Contact:	John Carullo
Phone:	214-683-0724
Date SummaryPrepared:	August 9, 2013
Device:
Trade Name:	Sunetics Clinical Laser "G" or "W2326"
Common/Classification Name:	Light Therapy Hair SystemProduct Code OAP; NHN21 C.F.R. § 890.5500 (Infrared lamp)
Classification:	Class II
PredicateDevices:	MEP-90 Hair Growth Stimulation System - Midwest RF LLC - K091496i grow II Hair Growth System - Apira Science Inc - K122248Theradome LH80 PRO Laser Helmet - Theradome Inc - K122950Theradome Laser Helmet LH80 PRO - Theradome Inc - K113097
DeviceDescription:	The Sunetics Clinical Laser (model "G" & model "W2326") is a stationary,non-invasive, low-level laser device intended to treat Androgenetic Alopecia(Hair Loss) and to promote hair growth in both Males and Females. TheSunetics Clinical Laser device provides distributed red laser light dispersingfrom an "Open Panel" Hood utilizing laser modules with a 650 nm wavelength.<5 mW output power, producing a continuous wave "CW" output beam. The"Open Panel" Hood is designed to maximize the delivery of the coherent laserlight 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
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.(b)
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.