Cleared Traditional

K031425 - GENTLEWAVES LED PHOTOMODULATION DEVICE

K031425 is an FDA 510(k) clearance for GENTLEWAVES LED PHOTOMODULATION DEVICE, manufactured by Light Bioscience, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 590-day FDA review.

K031425 · Light Bioscience, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
590d
Days
Class 2
Risk

K031425 is an FDA 510(k) clearance for the GENTLEWAVES LED PHOTOMODULATION DEVICE. 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 Light Bioscience, LLC (Leesburg, US). The FDA issued a Cleared decision on December 15, 2004 after a review of 590 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K031425

510(k) Number K031425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2003
Decision Date December 15, 2004
Days to Decision 590 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
475d slower than avg
Panel avg: 115d · This submission: 590d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEX Device Classification - Class 2, Special Controls

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 2870
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K031425.
MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS
K042000 · Msq (M2) , Ltd. · Dec 2004
CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES
K043319 · Novalis Medical, LLC · Dec 2004
OPUSDUO
K040270 · Lumenis, Ltd. · Dec 2004
ULTRALIGHT II ND:YAG LASER SYSTEM
K041011 · Sandstone Medical Technologies, LLC · Dec 2004
MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
K042785 · Nidek, Inc. · Dec 2004
PANALIGHT-BLU, MODEL 4175
K043164 · Dusa Pharmaceuticals, Inc. · Dec 2004
K031425 · GENTLEWAVES LED PHOTOMODULATION DEVICE
Download PDF Light Bioscience, LLC