Cleared Traditional

K895945 - KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG MODULE

K895945 is an FDA 510(k) clearance for KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG..., manufactured by Laserscope. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K895945 · Laserscope · General & Plastic Surgery device
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Apr 1990
Decision
180d
Days
Class 2
Risk

K895945 is an FDA 510(k) clearance for the KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG MODULE. 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 Laserscope (San Jose, US). The FDA issued a Cleared decision on April 9, 1990 after a review of 180 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 Laserscope devices

FDA 510(k) Submission Details - K895945

510(k) Number K895945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1989
Decision Date April 09, 1990
Days to Decision 180 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 115d · This submission: 180d
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 2239
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K895945.
F300 SERIES CONTACT FIBER HANDPIECES
K901021 · Hgm Medical Laser Systems, Inc. · Apr 1990
LASER LAPAROSCOPIC CHOLECYSTECTOMY
K901541 · Surgical Laser Technologies, Inc. · Apr 1990
SHARPLAN ND:YAG LASERS FOR ENT AND NECK SURGERY
K900345 · Sharplan Lasers, Inc. · 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