Cleared Special

PEREGRINE 23GA CURVED LASER PROBE

K122905 · Peregrine Surgical , Ltd. · Ophthalmic
Apr 2013
Decision
221d
Days
Class 2
Risk

About This 510(k) Submission

K122905 is an FDA 510(k) clearance for the PEREGRINE 23GA CURVED 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 April 30, 2013, 221 days after receiving the submission on September 21, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4690.

Submission Details

510(k) Number K122905 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2012
Decision Date April 30, 2013
Days to Decision 221 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

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