Clearance Summary
PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 received FDA 510(k) clearance under submission number K031023, sponsored by Peregrine Surgical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2003-06-27.
- Submission: K031023
- Applicant / Sponsor: Peregrine Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 2003-06-27
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.