Clearance Summary
Laser Hair Therapy received FDA 510(k) clearance under submission number K183329, sponsored by Omm Imports, Inc. D/B/A Zero Gravity. 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 2019-01-16.
- Submission: K183329
- Applicant / Sponsor: Omm Imports, Inc. D/B/A Zero Gravity
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2019-01-16
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.