Cleared Traditional

K895347 - MICRORUPTOR III SYSTEM, CW ND: YAG LASER COMPONENT

K895347 is an FDA 510(k) clearance for MICRORUPTOR III SYSTEM, manufactured by Lasag Medical Lasers. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K895347 · Lasag Medical Lasers · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 1990
Decision
213d
Days
Class 2
Risk

K895347 is an FDA 510(k) clearance for the MICRORUPTOR III SYSTEM, CW ND: YAG LASER COMPONENT. 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 Lasag Medical Lasers (Eden Prairie, US). The FDA issued a Cleared decision on April 2, 1990 after a review of 213 days - an extended review 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: 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 Lasag Medical Lasers devices

FDA 510(k) Submission Details - K895347

510(k) Number K895347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1989
Decision Date April 02, 1990
Days to Decision 213 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
98d slower than avg
Panel avg: 115d · This submission: 213d
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 2488
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K895347.
KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG MODULE
K895945 · Laserscope · Apr 1990
MODEL 20-CH CARBON DIOXIDE LASER W/ADD'L USES
K900253 · Pfizer Laser Systems · Apr 1990
SHARPLAN ND:YAG LASER LAPAROSCOPIC CHOLECYSTECTOMY
K900346 · Sharplan Lasers, Inc. · Apr 1990
NIDEK, INC. MODELS YC-1100 OPHTHALMIC LASERS
K900166 · Nidek, Inc. · Mar 1990
SHARPLAN MODEL 1055 SEALED CO2 SURGICAL LASER
K900592 · Sharplan Lasers, Inc. · Mar 1990
SHARPLAN FLEXIBLE CO2 SURGICAL LASER APPLICATOR
K900076 · Sharplan Lasers, Inc. · Mar 1990