Sunetics Clinical Bio-Stimulation Laser
FDA 510(k) K132646 · Sunetics International Marketing Group, LLC
510(k) numberK132646
Submission
- Device name
- Sunetics Clinical Bio-Stimulation Laser
- Applicant
- Sunetics International Marketing Group, LLC
Rockwall, TX, US - Received
- August 26, 2013
- Decision date
- December 20, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OAP – Laser, Comb, Hair
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
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| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)OAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 10/30/2025SE |
| K252325 | Hair Growth Laser CapOAP · Traditional | Cosmo Far East Technology Limited | 10/22/2025SE |
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More from Shenzhen Kaiyan Medical Equipment Co., Ltd.
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|---|---|---|
| K121920 | LaserbrushOAP · Traditional | 06/27/2013SE |
Questions and answers
When was Sunetics Clinical Bio-Stimulation Laser cleared by the FDA?
Sunetics Clinical Bio-Stimulation Laser (K132646) received a 510(k) decision of Substantially Equivalent on December 20, 2013, 116 days after the submission was received.
What is the product code of K132646?
The FDA product code is OAP – Laser, Comb, Hair, a Class II (moderate risk) device regulated under 21 CFR 890.5500.