(116 days)
Not Found
No
The summary describes a low-level laser device for hair growth and does not mention any AI or ML components or functionalities.
Yes
The device is indicated to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth, which are therapeutic medical conditions.
No
The device is described as a non-invasive, low-level laser device intended to treat hair loss and promote hair growth. Its function is therapeutic, not diagnostic.
No
The device description clearly states it is a "stationary, non-invasive, low-level laser device" utilizing an "Open Panel" Hood and laser modules. This indicates a physical hardware component is the primary mechanism of action, not software alone.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat hair loss and promote hair growth. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a laser device that applies light to the scalp. This is a physical intervention, not a test performed on a biological sample.
- Lack of IVD characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), reagents, or diagnostic assays, which are hallmarks of IVD devices.
The device is a therapeutic medical device used for a physical treatment.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OAP, NHN
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,
§ 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.
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DEC 2 0 2013
ATTACHMENT 2
510(k) SUMMARY
| 510(k) Owner: | Sunetics International Marketing Group LLC
892 Steger Towne Rd Suite # 44
Rockwall, TX 75032 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | John Carullo |
| Phone: | 214-683-0724 |
| Date Summary
Prepared: | August 9, 2013 |
| Device: | |
| Trade Name: | Sunetics Clinical Laser "G" or "W2326" |
| Common/Classification Name: | Light Therapy Hair System
Product Code OAP; NHN
21 C.F.R. § 890.5500 (Infrared lamp) |
| Classification: | Class II |
| 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 |
| 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.
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.
2
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
4
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