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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 116d · 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 Consultant

Underwriters Laboratories, Inc.
JEFFREY RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ILY Lamp, Infrared, Therapeutic Heating

All 222
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K073352.
ML830TP
K080786 · Microlight Corporation of America · Oct 2008
MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER
K082707 · Medx Electronics, Inc. · Oct 2008
TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM
K080102 · Escada International, Inc. · Aug 2008
WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES
K080465 · Ws Far IR Medical Technology Co., Ltd. · Jul 2008
SPECTRA THERAPY SYSTEM A1000 LASER DEVICE
K080689 · Premier Dynamics, Inc. · Jul 2008
DEL SOL RED LIGHT THERAPY SYSTEM
K072399 · Edge Systems, Inc. · May 2008

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K073352 · WEBERNEEDLE BASIC LASER
Download PDF FDA Summary Weber Medical GmbH