Cleared Traditional

PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10

K031023 · Peregrine Surgical , Ltd. · Ophthalmic
Jun 2003
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K031023 is an FDA 510(k) clearance for the PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Peregrine Surgical , Ltd. (New Britain, US). The FDA issued a Cleared decision on June 27, 2003, 88 days after receiving the submission on March 31, 2003. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K031023 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2003
Decision Date June 27, 2003
Days to Decision 88 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQF — Laser, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4390