Clearance Summary
SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR received FDA 510(k) clearance under submission number K081946, sponsored by Quantel Medical. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2009-03-25.
- Submission: K081946
- Applicant / Sponsor: Quantel Medical
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 2009-03-25
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.