Clearance Summary
SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313 received FDA 510(k) clearance under submission number K760519, sponsored by Dermatron Corp.. 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 1976-09-03.
- Submission: K760519
- Applicant / Sponsor: Dermatron Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 1976-09-03
Classification & Regulation
This clearance is catalogued under FDA product code IOB and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.