Cleared Traditional

K895239 - MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER

K895239 is an FDA 510(k) clearance for MODEL IR107 50-WATT CARBON-DIOXIDE SURG..., manufactured by Niic U.S.A., Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K895239 · Niic U.S.A., Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Nov 1989
Decision
87d
Days
Class 2
Risk

K895239 is an FDA 510(k) clearance for the MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER. 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 Niic U.S.A., Inc. (Redwood City, US). The FDA issued a Cleared decision on November 16, 1989 after a review of 87 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 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 Niic U.S.A., Inc. devices

FDA 510(k) Submission Details - K895239

510(k) Number K895239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1989
Decision Date November 16, 1989
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
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 2395
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K895239.
SITE 810E PHOTOCOAGULATOR AND ACCESSORIES
K895663 · Site Microsurgical Systems, Inc. · Dec 1989
COHERENT HOLMIUM:YAG SURGICAL LASER
K895518 · Lumenis, Inc. · Nov 1989
HERAEUS LASERSONICS ND:YAG LASER, MODEL LUXUS 100
K895430 · Heraeus Lasersonics, Inc. · Nov 1989
SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERY
K894471 · Surgilase, Inc. · Nov 1989
ENDOGUIDE PRODUCT LINE: EX0120, EX0300 AND EX0400
K895786 · Luxar Corp. · Oct 1989
ILLUMINA MODEL 25, 40 AND 55 CO2 LASER SYSTEMS
K895263 · Heraeus Lasersonics, Inc. · Oct 1989