Cleared Traditional

K022839 - FOTONA DUALIS PLUS ND:YAG LASER SYSTEM

K022839 is an FDA 510(k) clearance for FOTONA DUALIS PLUS ND:YAG LASER SYSTEM, manufactured by Fotona D.D.. 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.

K022839 · Fotona D.D. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Nov 2002
Decision
90d
Days
Class 2
Risk

K022839 is an FDA 510(k) clearance for the FOTONA DUALIS PLUS ND:YAG 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 Fotona D.D. (Ljubljana, SI). The FDA issued a Cleared decision on November 25, 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.

View all Fotona D.D. devices

FDA 510(k) Submission Details - K022839

510(k) Number K022839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2002
Decision Date November 25, 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 1451
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K022839.
FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM
K021548 · Fotona D.D. · Dec 2002
FOTONA TANDEM LASER SYSTEM
K022837 · Fotona D.D. · Nov 2002
FOTONA DUALIS ER:YAG/KTP LASER SYSTEM
K022838 · Fotona D.D. · Nov 2002
COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II
K022817 · Icn Pharmaceuticals, Inc. · Nov 2002
CYNOSURE PHOTOGENICA SV
K021444 · Cynosure, Inc. · Nov 2002
MILLENNIUM MICROSURGICAL SYSTEM
K022760 · Bausch & Lomb, Inc. · Nov 2002