Cleared Traditional

K942343 - LASEAWAY Q-SWITCHED RUBY LASER SYSTEM

K942343 is an FDA 510(k) clearance for LASEAWAY Q-SWITCHED RUBY LASER SYSTEM, manufactured by Polytec Pi, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K942343 · Polytec Pi, Inc. · General & Plastic Surgery device
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Jul 1994
Decision
53d
Days
Class 2
Risk

K942343 is an FDA 510(k) clearance for the LASEAWAY Q-SWITCHED RUBY 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 Polytec Pi, Inc. (Auburn, US). The FDA issued a Cleared decision on July 8, 1994 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 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 Polytec Pi, Inc. devices

FDA 510(k) Submission Details - K942343

510(k) Number K942343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1994
Decision Date July 08, 1994
Days to Decision 53 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 115d · This submission: 53d
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 1884
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K942343.
CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND
K942152 · Candela Laser Corp. · Jul 1994
ECLIPSE 3200
K943311 · Cardiogenes · Jul 1994
COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODELS A & B
K933318 · Lumenis, Inc. · Jul 1994
MEGABEAM DENTAL FIBER
K942182 · Ceram Optec, Inc. · Jul 1994
SHARPLAN SWIFTLASE 765/766/767 FLASHSCAN
K941312 · Sharplan Lasers, Inc. · Jun 1994
OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM
K932883 · Trimedyne, Inc. · Jun 1994