Clearance Summary
ISL QC 2000 received FDA 510(k) clearance under submission number K892058, sponsored by Intelligent Surgical Lasers, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1989-06-15.
- Submission: K892058
- Applicant / Sponsor: Intelligent Surgical Lasers, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4392
- Decision date: 1989-06-15
Classification & Regulation
This clearance is catalogued under FDA product code LXS and 21 CFR 886.4392, within the Ophthalmic review panel as a Class II device.