Cleared Traditional

KTP/532, KTP/YAG AND KTP/YAG XP (K931445) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931445 · Laser Surgical Systems · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
620d
Days
Class 2
Risk

K931445 is an FDA 510(k) clearance for the KTP/532, KTP/YAG AND KTP/YAG XP. 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 Laser Surgical Systems (San Jose, US). The FDA issued a Cleared decision on December 2, 1994 after a review of 620 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Laser Surgical Systems devices

Submission Details

510(k) Number K931445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1993
Decision Date December 02, 1994
Days to Decision 620 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
505d slower than avg
Panel avg: 115d · This submission: 620d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 527
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K931445.
ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE
K090084 · Merit Medical Systems, Inc. · Mar 2009
STRAIGHT FIRE HOLMIUM LASER FIBER
K082928 · Boston Scientific Corp · Oct 2008
CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES
K052680 · KARL STORZ Endoscopy-America, Inc. · Jan 2006
KARL STORZ LASER ACCESSORIES
K942786 · KARL STORZ Endoscopy-America, Inc. · Sep 1994
BOSTON SCIENTIFIC CORPORATION SIDE FIRING LASER GUIDE
K933715 · Boston Scientific Corp · Nov 1993
FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM
K880061 · Abbott Laboratories · Jun 1988