Cleared Special

23GA CURVED ILLUMINATING LASER PROBE

K122997 · Peregrine Surgical , Ltd. · Ophthalmic
Jun 2013
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K122997 is an FDA 510(k) clearance for the 23GA CURVED ILLUMINATING LASER PROBE, a Photocoagulator And Accessories (Class II — Special Controls, product code HQB), submitted by Peregrine Surgical , Ltd. (New Britain, US). The FDA issued a Cleared decision on June 26, 2013, 272 days after receiving the submission on September 27, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4690.

Submission Details

510(k) Number K122997 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2012
Decision Date June 26, 2013
Days to Decision 272 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQB — Photocoagulator And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4690

Similar Devices — HQB Photocoagulator And Accessories

All 29
Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
K220263 · Vortex Surgical, Inc. · Nov 2022
MAXReach Laser Probe
K191846 · Vortex Surgical, Inc. · Dec 2019
Vitreq disposable laser probes, light fibers and Chandelier
K182646 · Vitreq BV · May 2019
PEREGRINE CURVED ILLUMINATING LASER PROBE
K132614 · Peregrine Surgical , Ltd. · Nov 2013
PEREGRINE 23GA CURVED LASER PROBE
K122905 · Peregrine Surgical , Ltd. · Apr 2013
SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE
K113857 · Synergetics, Inc. · Apr 2012