Cleared Traditional

K882952 - CO2 SURGICAL LASER SYSTEM MODEL #IR106

K882952 is an FDA 510(k) clearance for CO2 SURGICAL LASER SYSTEM MODEL #IR106, 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 111-day FDA review.

K882952 · Niic U.S.A., Inc. · General & Plastic Surgery device
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Nov 1988
Decision
111d
Days
Class 2
Risk

K882952 is an FDA 510(k) clearance for the CO2 SURGICAL LASER SYSTEM MODEL #IR106. 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 2, 1988 after a review of 111 days - within the typical 510(k) review window.

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

View all Niic U.S.A., Inc. devices

FDA 510(k) Submission Details - K882952

510(k) Number K882952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1988
Decision Date November 02, 1988
Days to Decision 111 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
4d faster than avg
Panel avg: 115d · This submission: 111d
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 2396
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K882952.
SHARPLAN-MEDILAS 4060N YAG LASER & SERIES 2900 TIP
K884994 · Sharplan Lasers, Inc. · Dec 1988
KTP/532 SURGICAL LASER
K884029 · Laserscope · Nov 1988
CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.
K883738 · Directed Energy, Inc. · Nov 1988
MODEL SL60 SURGILASE CO2 SURGICAL LASER SYSTEMS
K884311 · Surgilase, Inc. · Oct 1988
MODEL SL45 SURGILASE CO2 SURGICAL LASER SYSTEMS
K884313 · Surgilase, Inc. · Oct 1988
SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80
K884092 · Surgilase, Inc. · Oct 1988