Cleared Traditional

K073352 - WEBERNEEDLE BASIC LASER

K073352 is an FDA 510(k) clearance for WEBERNEEDLE BASIC LASER, manufactured by Weber Medical GmbH. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K073352 · Weber Medical GmbH · Physical Medicine device
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Aug 2008
Decision
256d
Days
Class 2
Risk

K073352 is an FDA 510(k) clearance for the WEBERNEEDLE BASIC LASER. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Weber Medical GmbH (Lauenförde, DE). The FDA issued a Cleared decision on August 11, 2008 after a review of 256 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 Weber Medical GmbH devices

FDA 510(k) Submission Details - K073352

510(k) Number K073352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2007
Decision Date August 11, 2008
Days to Decision 256 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 115d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 39
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K073352.
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
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