Clearance Summary
IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS received FDA 510(k) clearance under submission number K031665, sponsored by Iridex Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2003-08-27.
- Submission: K031665
- Applicant / Sponsor: Iridex Corp
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 2003-08-27
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.