Cleared Traditional

K120604 - K-LASER

K120604 is an FDA 510(k) clearance for K-LASER, manufactured by Eltech S.R.L. The device is a Class 2 General & Plastic Surgery device with product code ILY cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K120604 · Eltech S.R.L · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
87d
Days
Class 2
Risk

K120604 is an FDA 510(k) clearance for the K-LASER. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Eltech S.R.L (Franklin, US). The FDA issued a Cleared decision on May 25, 2012 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 890.5500 - 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 Eltech S.R.L devices

FDA 510(k) Submission Details - K120604

510(k) Number K120604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2012
Decision Date May 25, 2012
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILY Device Classification - Class 2, Special Controls

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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 - ILY Lamp, Infrared, Therapeutic Heating

All 38
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K120604.
CYNOSURE 1064NM DIODE LASER
K123971 · Cynosure, Inc. · May 2013
ASA LASER SH1
K122125 · El.En Electronic Engineering Spa · Jan 2013
HEALITE II SYSTEM
K113668 · Lutronic Corporation · Jun 2012
DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE
K113250 · Dynatronics Corp. · Feb 2012
ASA 'MPHI FAMILY DIODE LASER
K111901 · Cynosure, Inc. · Nov 2011
ELECTRO-LIGHT THERAPY
K090250 · Hill Laboratories Co. · Feb 2010