Cleared Abbreviated

VARILITE LASER SYSTEM (K041930) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K041930 · Iridex Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
53d
Days
Class 2
Risk

K041930 is an FDA 510(k) clearance for the VARILITE LASER SYSTEM. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Iridex Corporation (Mountain View, US). The FDA issued a Cleared decision on September 10, 2004 after a review of 53 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Iridex Corporation devices

Submission Details

510(k) Number K041930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2004
Decision Date September 10, 2004
Days to Decision 53 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 115d · This submission: 53d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

Device Classification

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 537
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K041930.
STRAIGHT FIRE HOLMIUM LASER FIBER
K082928 · Boston Scientific Corp · Oct 2008
CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES
K052680 · KARL STORZ Endoscopy-America, Inc. · Jan 2006
EDWARDS E360 SURGICAL ABLATION DEVICE
K041739 · Edwards Lifesciences, LLC · Sep 2004
INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS
K023182 · Ethicon Endo-Surgery, Inc. · Oct 2002
INDIGO OPTIMA LASER SYSTEM
K013493 · Ethicon Endo-Surgery, Inc. · Dec 2001
INDIGO LASEROPTIC TREATMENT SYSTEM
K003952 · Ethicon Endo-Surgery, Inc. · Mar 2001