Clearance Summary
LC-250 INFRARED LIGHT COAGULATOR received FDA 510(k) clearance under submission number K964380, sponsored by Nk-Optik America. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1997-01-22.
- Submission: K964380
- Applicant / Sponsor: Nk-Optik America
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4690
- Decision date: 1997-01-22
Classification & Regulation
This clearance is catalogued under FDA product code HQB and 21 CFR 886.4690, within the Ophthalmic review panel as a Class II device.