Clearance Summary
FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM received FDA 510(k) clearance under submission number K880061, sponsored by Abbott Laboratories. 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 1988-06-20.
- Submission: K880061
- Applicant / Sponsor: Abbott Laboratories
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1988-06-20
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.