Cleared Traditional

K143723 - SP Dynamis

K143723 is an FDA 510(k) clearance for SP Dynamis, 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 101-day FDA review.

K143723 · Fotona D.D. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
101d
Days
Class 2
Risk

K143723 is an FDA 510(k) clearance for the SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro. 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 April 9, 2015 after a review of 101 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 - K143723

510(k) Number K143723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2014
Decision Date April 09, 2015
Days to Decision 101 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
14d faster than avg
Panel avg: 115d · This submission: 101d
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 K143723.
The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch
K151331 · Lumenis, Ltd. · Jun 2015
MCL 31 Dermablate
K150140 · Asclepion Laser Technologies GmbH · Jun 2015
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS
K150516 · El.En Electronic Engineering Spa · Apr 2015
COOK HOLMIUM LASER FIBER
K133788 · Cook Incorporated · Mar 2015
The MeDioStar NeXT Family
K143519 · Asclepion Laser Technologies GmbH · Mar 2015
Picosure Workstation
K143105 · Cynosure, Inc. · Feb 2015