Cleared Traditional

K013941 - PULSION FS LASER KERATOME

K013941 is an FDA 510(k) clearance for PULSION FS LASER KERATOME, manufactured by Intra Lase Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013941 · Intra Lase Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
90d
Days
Class 2
Risk

K013941 is an FDA 510(k) clearance for the PULSION FS LASER KERATOME. 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 Intra Lase Corp. (Irvine, US). The FDA issued a Cleared decision on February 27, 2002 after a review of 90 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K013941

510(k) Number K013941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2001
Decision Date February 27, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
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 2836
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K013941.
DERMASTAR ER:YAG LASER SYSTEM
K014057 · Asclepion-Meditec AG · Mar 2002
COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS
K014035 · Cooltouch Corp. · Mar 2002
DIODENT DENTAL LASER SYSTEM
K013216 · Continuum Electro-Optics, Inc. · Feb 2002
DEPILASE YAG LASE PLUS LASER SYSTEM
K020463 · Depilase Group , Ltd. · Feb 2002
LASER SYSTEM YELLOWSTAR
K013940 · Asclepion-Meditec AG · Feb 2002
DEPILASE TWIN LASE LASER SYSTEM
K020412 · Depilase Group , Ltd. · Feb 2002
K013941 · PULSION FS LASER KERATOME
Download PDF FDA Summary Intra Lase Corp.