Cleared Special

K130729 - EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER

K130729 is an FDA 510(k) clearance for EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER, manufactured by Dornier Medtech Systems. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Special 510(k) pathway after a 57-day FDA review.

K130729 · Dornier Medtech Systems · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
57d
Days
Class 2
Risk

K130729 is an FDA 510(k) clearance for the EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Dornier Medtech Systems (Kennesaw, US). The FDA issued a Cleared decision on May 14, 2013 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5990 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dornier Medtech Systems devices

FDA 510(k) Submission Details - K130729

510(k) Number K130729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2013
Decision Date May 14, 2013
Days to Decision 57 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 130d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

LNS Device Classification - Class 2, Special Controls

Product Code LNS Lithotriptor, Extracorporeal Shock-wave, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5990
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - LNS Lithotriptor, Extracorporeal Shock-wave, Urological

All 18
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K130729.
Modulith SLX-F2
K201001 · Karl Storz Endoscopy America · Mar 2021
Delta III Lithotripter
K201074 · Dornier Medtech America, Inc. · Sep 2020
Delta III Lithotripter
K172084 · Dornier Medtech America, Inc. · Aug 2017
GEMINI LITHOTRIPTER
K121656 · Dornier Medtech America, Inc. · Sep 2012
MODULTH SLK
K120769 · KARL STORZ Endoscopy-America, Inc. · Jun 2012
LITHOSKOP
K070665 · Siemens Medical Solutions USA, Inc. · Jan 2008