Clearance Summary
BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS received FDA 510(k) clearance under submission number K022128, sponsored by Bausch & Lomb, Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2002-08-22.
- Submission: K022128
- Applicant / Sponsor: Bausch & Lomb, Incorporated
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5916
- Decision date: 2002-08-22
Classification & Regulation
This clearance is catalogued under FDA product code HQD and 21 CFR 886.5916, within the Ophthalmic review panel as a Class II device.