(360 days)
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.
The Sunetics LaserBrush consists of a handheld low-level laser device intended to promote hair growth. Depending upon the Sunetics LaserBrush model, the device provides distributed laser light using seven (7), nine (9), or twelve (12), collimated, 650 nm, <5 mW laser modules, while brush bristles simultaneously part the user's hair to ensure that the laser light reaches the user's scalp.
The provided 510(k) submission for the Sunetics LaserBrush does not include a study demonstrating device performance against specific acceptance criteria relevant to an AI/ML medical device. The submission focuses on substantial equivalence to a predicate device (HairMax LaserCombs) through comparison of technological characteristics.
Therefore, the following information is not present in the provided text:
- A table of acceptance criteria and reported device performance (in the context of AI/ML performance metrics).
- Sample size for the test set or data provenance for an AI/ML study.
- Number of experts or their qualifications for establishing ground truth for an AI/ML study.
- Adjudication method for an AI/ML study.
- Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done or its effect size.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used for an AI/ML study.
- Sample size for the training set for an AI/ML model.
- How ground truth for the training set was established for an AI/ML model.
What is provided regarding performance:
The submission states under "Performance Data":
"The laser wavelength, average and peak power levels, laser treatment field and energy delivery of the Sunetics LaserBrush and the Lexington Hairmax LaserComb were substantially equivalent."
And in the "Conclusions":
"The performance data discussed above demonstrate that the Sunetics LaserBrush device is as safe and effective as the predicate device."
This indicates that the "performance data" refers to the physical and operational characteristics of the laser device being comparable to the predicate, rather than clinical efficacy data generated from a new trial or AI/ML performance metrics. The FDA's 510(k) clearance confirms substantial equivalence based on these comparisons.
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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 LLC892 Steger Towne Rd Suite # 44Rockwall, TX 75032Contact:John CarulloPhone:214-683-0724 | |
|---|---|---|
| Date SummaryPrepared: | June 21, 2012 | |
| Device: | Trade Name: | Sunetics LaserBrush |
| Common/Classification Name: | Laser, Comb, HairProduct Code OAP | |
| 21 C.F.R. § 890.5500 (Infrared lamp) | ||
| Classification: | Class II | |
| PredicateDevice: | HairMax LaserCombs - models: Advanced 7, Lux 9, Professional 12Lexington International, LLCK110233, K103368, Κ112524 | |
| DeviceDescription: | The Sunetics LaserBrush consists of a handheld low-level laser deviceintended to promote hair growth. Depending upon the Sunetics LaserBrushmodel, the device provides distributed laser light using seven (7), nine (9), ortwelve (12), collimated, 650 nm, <5 mW laser modules, while brush bristlessimultaneously part the user's hair to ensure that the laser light reaches theuser's scalp. | |
| Intended Use: | The Sunetics LaserBrush is indicated to treat Androgenetic Alopecia,promote hair growth and prevent further hair loss in males who haveNorwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I toIV & also in females who have Ludwig (Savin) I-4, II-1, II-2, or frontalpatterns of hair loss & Fitzpatrick Skin Types I to IV. | |
| TechnologicalCharacteristics: | The Sunetics LaserBrush has the same intended power, wavelength, energysource, laser beam pattern, laser treatment field, consumer usage focal point,energy delivery, power supply, treatment time, indication for use, and targetpopulation as the Hairmax LaserComb.Not applicable. | |
| BiocompatibilityData: | ||
| PerformanceData: | The laser wayeth length, average and peak power levels, laser treatment fieldand energy delivery of the Sunetics LaserBrush and the Lexington HairmaxLaserComb were substantially equivalent. | |
| Conclusions: | The performance data discussed above demonstrate that the SuneticsLaserBrush 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 (800) 638-2041 or (301) 796-7100 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
§ 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.