Clearance Summary
FIBER OPTIC LIGHT CABLE received FDA 510(k) clearance under submission number K903800, sponsored by Orlux Engineering and Instrumentation. 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 1990-08-29.
- Submission: K903800
- Applicant / Sponsor: Orlux Engineering and Instrumentation
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 1990-08-29
Classification & Regulation
This clearance is catalogued under FDA product code FST and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.