Cleared Abbreviated

K043586 - LASER SYS*STIM 540

K043586 is the FDA 510(k) clearance for LASER SYS*STIM 540 by Mettler Electronics Corp.. It is a Class 2 Physical Medicine device (product code ILY) cleared through the Abbreviated 510(k) pathway after a 129-day FDA review.

K043586 · Mettler Electronics Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
129d
Days
Class 2
Risk

K043586 is an FDA 510(k) clearance for the LASER SYS*STIM 540, MODEL ME 540. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on May 6, 2005 after a review of 129 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Mettler Electronics Corp. devices

Submission Details

510(k) Number K043586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2004
Decision Date May 06, 2005
Days to Decision 129 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 115d · This submission: 129d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 16
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K043586.
ASA 'MPHI FAMILY DIODE LASER
K111901 · Cynosure, Inc. · Nov 2011
HILT FAMILY LASER: HILT I, HILT II, HILT III
K051537 · Cynosure, Inc. · Sep 2005
ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6
K051922 · Cynosure, Inc. · Sep 2005
RICH-MAR AUTOPRISM INFRARED LAMP
K040679 · Rich-Mar Corp. · May 2004
SURGICAL PATIENT WARMER, MODEL PW820 JHU
K022609 · Fisher &Paykel Healthcare , Ltd. · Mar 2003
OLYMPIC WARM-UP
K001056 · Olympic Medical Corp. · Sep 2000