Clearance Summary
MAINSTER HIGH MAGNIFICATION LASER LENS received FDA 510(k) clearance under submission number K912366, sponsored by Ocular 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 1991-06-25.
- Submission: K912366
- Applicant / Sponsor: Ocular Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1385
- Decision date: 1991-06-25
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.