Cleared Traditional

K931490 - SLT MULTIDIMENSIONAL CONTACT LASER SYST...

K931490 is an FDA 510(k) clearance for SLT MULTIDIMENSIONAL CONTACT LASER SYST..., manufactured by Surgical Laser Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 771-day FDA review.

K931490 · Surgical Laser Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
771d
Days
Class 2
Risk

K931490 is an FDA 510(k) clearance for the SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM FAMILY. 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 Surgical Laser Technologies, Inc. (Oaks, US). The FDA issued a Cleared decision on May 5, 1995 after a review of 771 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 Surgical Laser Technologies, Inc. devices

FDA 510(k) Submission Details - K931490

510(k) Number K931490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1993
Decision Date May 05, 1995
Days to Decision 771 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
656d slower than avg
Panel avg: 115d · This submission: 771d
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 1544
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K931490.
SHARPLAN MODEL 712 ACUSPOT MICROMANIPULATOR
K951204 · Sharplan Lasers, Inc. · Jun 1995
ALEXLAZR
K950831 · Candela Laser Corp. · May 1995
ADD POWER FAMILY , MICRO ADDSTAT
K945614 · Laserscope · May 1995
SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER)
K950819 · Surgical Laser Technologies, Inc. · Apr 1995
AURA LASER SYSTEM
K951034 · Laserscope · Apr 1995
SHARPLAN MODEL 1015 CO2 LASER
K950725 · Sharplan Lasers, Inc. · Apr 1995