Clearance Summary
PEREGRINE CURVED ILLUMINATING LASER PROBE received FDA 510(k) clearance under submission number K132614, sponsored by Peregrine Surgical , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2013-11-14.
- Submission: K132614
- Applicant / Sponsor: Peregrine Surgical , Ltd.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4690
- Decision date: 2013-11-14
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.