Clearance Summary
LPULSA SYL-9000 OPHTHALMIC YAG LASER received FDA 510(k) clearance under submission number K990075, sponsored by Light-Med(Usa), 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 1999-03-30.
- Submission: K990075
- Applicant / Sponsor: Light-Med(Usa), Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 1999-03-30
Classification & Regulation
This clearance is catalogued under FDA product code HQF and 21 CFR 886.4390, within the Ophthalmic review panel as a Class II device.