Cleared Traditional

K091158 - SCALAR WAVE LASER SYSTEM

K091158 is an FDA 510(k) clearance for SCALAR WAVE LASER SYSTEM, manufactured by Stellar Lasers. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K091158 · Stellar Lasers · Physical Medicine device
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Aug 2009
Decision
111d
Days
Class 2
Risk

K091158 is an FDA 510(k) clearance for the SCALAR WAVE LASER SYSTEM. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Stellar Lasers (Greenwood Village, US). The FDA issued a Cleared decision on August 10, 2009 after a review of 111 days - within the typical 510(k) review window.

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 Stellar Lasers devices

FDA 510(k) Submission Details - K091158

510(k) Number K091158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2009
Decision Date August 10, 2009
Days to Decision 111 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 115d · This submission: 111d
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 38
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K091158.
ASA 'MPHI FAMILY DIODE LASER
K111901 · Cynosure, Inc. · Nov 2011
ELECTRO-LIGHT THERAPY
K090250 · Hill Laboratories Co. · Feb 2010
THERMAPULSE
K092222 · Palomar Medical Products, Inc. · Aug 2009
AKLARUS PHOTOTHERAPY SYSTEM
K083183 · Hill Laboratories Co. · Jul 2009
EZLASE
K083595 · Biolase Technology, Inc. · Apr 2009
DYNATRON DX2 TRACTION UNIT
K051680 · Dynatronics Corp. · Oct 2005