Cleared Traditional

K131095 - DEKA SYNCHRO REPLA: Y FAMILY OF LASER S...

K131095 is the FDA 510(k) clearance for DEKA SYNCHRO REPLA: Y FAMILY OF LASER S... by El.En Electronic Engineering Spa. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K131095 · El.En Electronic Engineering Spa · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
231d
Days
Class 2
Risk

K131095 is an FDA 510(k) clearance for the DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS. 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 El.En Electronic Engineering Spa (Calenzano, IT). The FDA issued a Cleared decision on December 5, 2013 after a review of 231 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 El.En Electronic Engineering Spa devices

Submission Details

510(k) Number K131095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2013
Decision Date December 05, 2013
Days to Decision 231 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
116d slower than avg
Panel avg: 115d · This submission: 231d
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 1171
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K131095.
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
K133254 · Cynosure, Inc. · Mar 2014
CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS
K133283 · Candela Corp. · Dec 2013
VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH
K133561 · AngioDynamics, Inc. · Dec 2013
(QUANTA SYSTEM) SURGICAL LASER FIBERS
K131473 · Quanta System Spa · Oct 2013
CYBER TM FAMILY
K131081 · Quanta System Spa · Jul 2013
MDK MULTI-APPLICATIONS PLATFORM
K130256 · Quanta System Spa · Jul 2013