Cleared Traditional

K980560 - FOTONA SKINPLUS LASER SYSTEM

K980560 is an FDA 510(k) clearance for FOTONA SKINPLUS 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 42-day FDA review.

K980560 · Fotona D.D. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
42d
Days
Class 2
Risk

K980560 is an FDA 510(k) clearance for the FOTONA SKINPLUS 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 March 27, 1998 after a review of 42 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 Fotona D.D. devices

FDA 510(k) Submission Details - K980560

510(k) Number K980560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1998
Decision Date March 27, 1998
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
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 K980560.
CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM
K974674 · Cynosure, Inc. · Apr 1998
SLT CL MD CONTACT LASER SYSTEM
K972548 · Surgical Laser Technologies, Inc. · Apr 1998
LASERSCOPE EL LASER SYSTEM AND ACCESSORIES
K974896 · Laserscope · Mar 1998
NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000
K974732 · Nidek, Inc. · Mar 1998
DIO-LIGHT LASER SYSTEM
K980201 · Nidek, Inc. · Mar 1998
COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L
K974789 · Lumenis, Inc. · Mar 1998