Cleared Traditional

K122125 - ASA LASER SH1

K122125 is an FDA 510(k) clearance for ASA LASER SH1, manufactured by El.En Electronic Engineering Spa. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K122125 · El.En Electronic Engineering Spa · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
191d
Days
Class 2
Risk

K122125 is an FDA 510(k) clearance for the ASA LASER SH1. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by El.En Electronic Engineering Spa (Calenzano, IT). The FDA issued a Cleared decision on January 25, 2013 after a review of 191 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all El.En Electronic Engineering Spa devices

FDA 510(k) Submission Details - K122125

510(k) Number K122125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2012
Decision Date January 25, 2013
Days to Decision 191 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 115d · This submission: 191d
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - ILY Lamp, Infrared, Therapeutic Heating

All 114
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K122125.
STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM
K123177 · Laserstim, Inc. · Jul 2013
CYNOSURE 1064NM DIODE LASER
K123971 · Cynosure, Inc. · May 2013
TENDER TOUCH
K121401 · Sometech Corporation · May 2013
BIOPHOTAS LIFELIGHT
K122237 · Biophotas, Inc. · Jan 2013
DIOWAVE LOW LEVEL COLD LASER SYSTEM
K121363 · Technological Medical Advancments, Inc. (Tma) · Nov 2012
CS1000 LIGHT THERAPY DEVICE
K110558 · Genesis Health Light Corporation · Jul 2012