Clearance Summary
ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 received FDA 510(k) clearance under submission number K012435, 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 2001-10-02.
- Submission: K012435
- Applicant / Sponsor: Bausch & Lomb, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 2001-10-02
Classification & Regulation
This clearance is catalogued under FDA product code NGY and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.