Cleared Traditional

K031023 - PEREGRINE ILLUMINATING LASER PROBE MODE...

K031023 is the FDA 510(k) clearance for PEREGRINE ILLUMINATING LASER PROBE MODE... by Peregrine Surgical , Ltd.. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K031023 · Peregrine Surgical , Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
88d
Days
Class 2
Risk

K031023 is an FDA 510(k) clearance for the PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Peregrine Surgical , Ltd. (New Britain, US). The FDA issued a Cleared decision on June 27, 2003 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Peregrine Surgical , Ltd. devices

Submission Details

510(k) Number K031023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 110d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQF Laser, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQF Laser, Ophthalmic

All 46
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K031023.
VISULAS green
K181682 · Carl Zeiss Meditec, AG · Mar 2019
PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
K180402 · Topcon Medical Laser Systems, Inc. · May 2018
MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
K033941 · Bausch & Lomb, Inc. · Feb 2004
DC-3300 LASER DIODE PHOTOCOAGULATOR
K013760 · Nidek, Inc. · Feb 2002
NIDEK MODEL GYC-1500 AND GYC-2000
K951079 · Nidek, Inc. · Sep 1995
KEELER MULTILASE 3000
K942180 · Keeler Instruments, Inc. · Nov 1994