Clearance Summary
PROVIEW EYE PRESSURE MONITOR received FDA 510(k) clearance under submission number K011199, sponsored by Bausch & Lomb, 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 2001-07-02.
- Submission: K011199
- Applicant / Sponsor: Bausch & Lomb, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 2001-07-02
Classification & Regulation
This clearance is catalogued under FDA product code HKY and 21 CFR 886.1930, within the Ophthalmic review panel as a Class II device.