Cleared Traditional

K131797 - 3B LASER NEEDLE

K131797 is an FDA 510(k) clearance for 3B LASER NEEDLE, manufactured by Livetec GmbH. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K131797 · Livetec GmbH · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
114d
Days
Class 2
Risk

K131797 is an FDA 510(k) clearance for the 3B LASER NEEDLE. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Livetec GmbH (Littleton, US). The FDA issued a Cleared decision on October 10, 2013 after a review of 114 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 Livetec GmbH devices

FDA 510(k) Submission Details - K131797

510(k) Number K131797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2013
Decision Date October 10, 2013
Days to Decision 114 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
1d faster than avg
Panel avg: 115d · This submission: 114d
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 K131797.
CytonPro-5000
K213524 · Cytonsys, Inc. · Aug 2022
dermalux Flex MD
K202028 · Aesthetic Technology, Ltd. · Dec 2020
LASER-STIM
K131259 · Shenzhen Dongdixin Technology Co., Ltd. · Dec 2013
CYNOSURE 1064NM DIODE LASER
K123971 · Cynosure, Inc. · May 2013
ASA LASER SH1
K122125 · El.En Electronic Engineering Spa · Jan 2013
HEALITE II SYSTEM
K113668 · Lutronic Corporation · Jun 2012