Cleared Traditional

K031665 - IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS

K031665 is an FDA 510(k) clearance for IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS, manufactured by Iridex Corp. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K031665 · Iridex Corp · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
90d
Days
Class 2
Risk

K031665 is an FDA 510(k) clearance for the IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Iridex Corp (Mountain View, US). The FDA issued a Cleared decision on August 27, 2003 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K031665

510(k) Number K031665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2003
Decision Date August 27, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQF Device Classification - Class 2, Special Controls

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 158
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K031665.
LASEREX, MODEL LP4532
K041598 · Ellex Medical Pty, Ltd. · Oct 2004
IRIS MEDICAL IQ 810 PHOTOCOAGULATOR
K040209 · Iridex Corp · Sep 2004
MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
K033941 · Bausch & Lomb, Inc. · Feb 2004
PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10
K031023 · Peregrine Surgical , Ltd. · Jun 2003
IRIDIS OPHTHALMIC PHOTOCOAGULATOR
K023094 · Quantel Medical · Dec 2002
LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
K021538 · Lightmed Corp. · Aug 2002
K031665 · IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS
Download PDF FDA Summary Iridex Corp