Cleared Traditional

K874948 - SUN MEDICAL SMOKE EVACUATOR SYSTEM

K874948 is an FDA 510(k) clearance for SUN MEDICAL SMOKE EVACUATOR SYSTEM, manufactured by Sun Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K874948 · Sun Medical, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 1988
Decision
78d
Days
Class 2
Risk

K874948 is an FDA 510(k) clearance for the SUN MEDICAL SMOKE EVACUATOR 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 Sun Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on February 18, 1988 after a review of 78 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 Sun Medical, Inc. devices

FDA 510(k) Submission Details - K874948

510(k) Number K874948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1987
Decision Date February 18, 1988
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
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 2352
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K874948.
COHERENT XA-40 CO2 SURGICAL LASER
K880603 · Coherent Medical Group · Mar 1988
MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.
K880216 · Directed Energy, Inc. · Mar 1988
INFRAGUIDE(TM)
K875115 · Cooper Lasersonics, Inc. · Feb 1988
MODEL 5202 MICROMANIPULATOR
K874811 · Coherent Medical Group · Feb 1988
COHERENT XA-30/SP CO2 SURGICAL LASER
K874648 · Coherent Medical Group · Feb 1988
MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY
K873790 · Cooper Lasersonics, Inc. · Jan 1988