Cleared Traditional

K893701 - SLT CONTACT LASER SYSTEM

K893701 is an FDA 510(k) clearance for SLT CONTACT LASER SYSTEM, 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 34-day FDA review.

K893701 · Surgical Laser Technologies, Inc. · General & Plastic Surgery device
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Jun 1989
Decision
34d
Days
Class 2
Risk

K893701 is an FDA 510(k) clearance for the SLT CONTACT 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 Surgical Laser Technologies, Inc. (Malvern, US). The FDA issued a Cleared decision on June 21, 1989 after a review of 34 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 Surgical Laser Technologies, Inc. devices

FDA 510(k) Submission Details - K893701

510(k) Number K893701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1989
Decision Date June 21, 1989
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
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 K893701.
CO2 LASER SYSTEMS & ARTHROGUIDE CO2 LASER FIBER
K893832 · Heraeus Lasersonics, Inc. · Aug 1989
OPMILAS CO2-L
K894393 · Carl Zeiss, Inc. · Jul 1989
SHARPLAN 1075 CO2 LASER
K893206 · Sharplan Lasers, Inc. · Jun 1989
CANDELA PLDL-1 PULSED DYE LASER
K892516 · Candela Laser Corp. · Jun 1989
PEGASUS
K885060 · Pfizer Laser Systems · Jun 1989
LIGHT-TOUCH/GS 905250 ND:YAG LASER MICRO PRO ENDOS
K891909 · Lifestream Int'L, Inc. · May 1989