Clearance Summary
DIGAPHOT PHOTOTHERAPY METER MODEL PT 145 received FDA 510(k) clearance under submission number K780162, sponsored by Cavitron Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1978-03-27.
- Submission: K780162
- Applicant / Sponsor: Cavitron Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 1978-03-27
Classification & Regulation
This clearance is catalogued under FDA product code FTA and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.