Clearance Summary
ZYOPTIX XP MICROKERATOME received FDA 510(k) clearance under submission number K040204, sponsored by Bausch & Lomb, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2004-03-22.
- Submission: K040204
- Applicant / Sponsor: Bausch & Lomb, Inc.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 2004-03-22
Classification & Regulation
This clearance is catalogued under FDA product code HNO and 21 CFR 886.4370, within the Ophthalmic review panel as a Class I device.