Cleared Special

K013901 - MALLEABLE SURGICAL LIGHTSTIC 180

K013901 is an FDA 510(k) clearance for MALLEABLE SURGICAL LIGHTSTIC 180, manufactured by Cardiofocus, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Special 510(k) pathway after a 24-day FDA review.

K013901 · Cardiofocus, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
24d
Days
Class 2
Risk

K013901 is an FDA 510(k) clearance for the MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM). 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 Cardiofocus, Inc. (Norton, US). The FDA issued a Cleared decision on December 20, 2001 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cardiofocus, Inc. devices

FDA 510(k) Submission Details - K013901

510(k) Number K013901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2001
Decision Date December 20, 2001
Days to Decision 24 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 1681
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K013901.
SMARTEPIL
K020107 · Cynosure, Inc. · Feb 2002
FOTONA DUALIS, FOTONA DUALIS PLUS
K011939 · Fotona D.D. · Dec 2001
MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
K013193 · Biolitec, Inc. · Dec 2001
INDIGO OPTIMA LASER SYSTEM
K013493 · Ethicon Endo-Surgery, Inc. · Dec 2001
PALOMAR SLP 1000
K013028 · Palomar Medical Products, Inc. · Dec 2001
DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE
K011322 · Dornier Medtech America, Inc. · Nov 2001