Clearance Summary
SUNETICS CLINICAL BIO-STIMULATION LASER received FDA 510(k) clearance under submission number K132646, sponsored by Sunetics International Marketing Group, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2013-12-20.
- Submission: K132646
- Applicant / Sponsor: Sunetics International Marketing Group, LLC
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2013-12-20
Classification & Regulation
This clearance is catalogued under FDA product code OAP and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.