Cleared Traditional

K013201 - CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K013201 · Cardiofocus, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
174d
Days
Class 2
Risk

K013201 is an FDA 510(k) clearance for the CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR. 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. (South West Ranches, US). The FDA issued a Cleared decision on March 18, 2002 after a review of 174 days - an extended review 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: 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.

View all Cardiofocus, Inc. devices

Submission Details

510(k) Number K013201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2001
Decision Date March 18, 2002
Days to Decision 174 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
60d slower than avg
Panel avg: 114d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 2855
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K013201.
YellowStar
K261094 · Asclepion Laser Technologies GmbH · Apr 2026
VANISH PRO
K253765 · Ddc Technologies, Inc. · Apr 2026
Q-Switched Nd: YAG Laser System (Glamor Q)
K260153 · Nanjing Bestview Laser S&T Co., Ltd. · Apr 2026
Diode Laser Therapy Systems (V19)
K260307 · Weifang Mingliang Electronics Co., Ltd. · Apr 2026
Picosecond Nd:YAG Laser Systems (Model: HS-298)
K260017 · Shanghai Apolo Medical Technology Co., Ltd. · Apr 2026
CO2 Laser System
K260257 · Sanhe Meditech Co., Ltd. · Mar 2026