Clearance Summary
I.V.E. REFRACTION SYSTEM received FDA 510(k) clearance under submission number K812896, 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 1981-12-02.
- Submission: K812896
- Applicant / Sponsor: Bausch & Lomb, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1760
- Decision date: 1981-12-02
Classification & Regulation
This clearance is catalogued under FDA product code HKO and 21 CFR 886.1760, within the Ophthalmic review panel as a Class I device.