Cleared Traditional

K953917 - LASESONICS LOW POWER CO2 LASER SYSTEM

K953917 is an FDA 510(k) clearance for LASESONICS LOW POWER CO2 LASER SYSTEM, manufactured by Heraeus Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K953917 · Heraeus Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
66d
Days
Class 2
Risk

K953917 is an FDA 510(k) clearance for the LASESONICS LOW POWER CO2 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 Heraeus Surgical, Inc. (Milpitas, US). The FDA issued a Cleared decision on October 26, 1995 after a review of 66 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 Heraeus Surgical, Inc. devices

FDA 510(k) Submission Details - K953917

510(k) Number K953917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1995
Decision Date October 26, 1995
Days to Decision 66 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
49d faster than avg
Panel avg: 115d · This submission: 66d
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 2269
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K953917.
OPTILITE VIII LASER SURGERY ACCESSORIES
K951760 · Xintec Corporation · Nov 1995
SHARPLAN MODEL 2040 PULSED CTH:YAG SURGICAL LASER SYSTEM
K952277 · Sharplan Lasers, Inc. · Nov 1995
SHARPLAN LASERS, INC. SURGICAL DIODE LASER
K953794 · Sharplan Lasers, Inc. · Nov 1995
CANDELA MODEL PLTL-1 LASER SYSTEM
K953412 · Candela Laser Corp. · Oct 1995
LIHTAN 532 LASER
K951117 · Buckman Co., Inc. · Oct 1995
SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940
K952661 · Surgical Laser Technologies, Inc. · Oct 1995