Clearance Summary
OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY received FDA 510(k) clearance under submission number K050541, sponsored by Omniguide Communications, 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 2005-05-09.
- Submission: K050541
- Applicant / Sponsor: Omniguide Communications, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 2005-05-09
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.