Clearance Summary
SUPER VIEW DISPOSABLE BIOM LENS SET received FDA 510(k) clearance under submission number K051630, sponsored by Insight Instruments, 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 2005-06-29.
- Submission: K051630
- Applicant / Sponsor: Insight Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1385
- Decision date: 2005-06-29
Classification & Regulation
This clearance is catalogued under FDA product code HJK and 21 CFR 886.1385, within the Ophthalmic review panel as a Class II device.