Clearance Summary
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS received FDA 510(k) clearance under submission number K001144, sponsored by Lasersight Technologies, 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 2000-05-05.
- Submission: K001144
- Applicant / Sponsor: Lasersight Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 2000-05-05
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.