Clearance Summary
HANSATOME MICROKERATOME received FDA 510(k) clearance under submission number K010260, 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 2001-04-27.
- Submission: K010260
- Applicant / Sponsor: Bausch & Lomb, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 2001-04-27
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.