Cleared Traditional

K070516 - POWERLASER

K070516 is an FDA 510(k) clearance for POWERLASER, manufactured by Powermedic Aps. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K070516 · Powermedic Aps · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
130d
Days
Class 2
Risk

K070516 is an FDA 510(k) clearance for the POWERLASER. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Powermedic Aps (Holbaek, DK). The FDA issued a Cleared decision on July 2, 2007 after a review of 130 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 Powermedic Aps devices

FDA 510(k) Submission Details - K070516

510(k) Number K070516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2007
Decision Date July 02, 2007
Days to Decision 130 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 115d · This submission: 130d
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 31
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K070516.
ASA 'MPHI FAMILY DIODE LASER
K111901 · Cynosure, Inc. · Nov 2011
THERMAPULSE
K092222 · Palomar Medical Products, Inc. · Aug 2009
EZLASE
K083595 · Biolase Technology, Inc. · Apr 2009
DYNATRON DX2 TRACTION UNIT
K051680 · Dynatronics Corp. · Oct 2005
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