Clearance Summary
PHOTOTHERAPEUTIX MODEL 1600B received FDA 510(k) clearance under submission number K935526, sponsored by Avex Industries , Ltd.. 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 1995-02-17.
- Submission: K935526
- Applicant / Sponsor: Avex Industries , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4630
- Decision date: 1995-02-17
Classification & Regulation
This clearance is catalogued under FDA product code FTC and 21 CFR 878.4630, within the General, Plastic Surgery review panel as a Class II device.