Clearance Summary
LASER INDIRECT OPHTHALMOSCOPE (LIO) received FDA 510(k) clearance under submission number K885196, sponsored by Coherent Medical Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1989-01-11.
- Submission: K885196
- Applicant / Sponsor: Coherent Medical Group
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4150
- Decision date: 1989-01-11
Classification & Regulation
This clearance is catalogued under FDA product code HQE and 21 CFR 886.4150, within the Ophthalmic review panel as a Class II device.