Lite-Med LM-9200 Elma

FDA 510(k) K103217 · Lite-Med, Inc.

Substantially Equivalent

510(k) numberK103217

Submission

Device name
Lite-Med LM-9200 Elma
Applicant
Lite-Med, Inc.
Taipei City, TW
Received
November 1, 2010
Decision date
September 28, 2011
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LNS – Lithotriptor, Extracorporeal Shock-Wave, Urological
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5990
Specialty
Gastroenterology, Urology

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K221903Delta III ProLNS · Traditional Dornier Medtech America, Inc.02/22/2023SE
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K201001Modulith SLX-F2LNS · Traditional Karl Storz Endoscopy America03/30/2021SE
K201074Delta III LithotripterLNS · Traditional Dornier Medtech America, Inc.09/03/2020SE
K172084Delta III LithotripterLNS · Special Dornier Medtech America, Inc.08/08/2017SE
K170122Delta III LithotripterLNS · Traditional Dornier Medtech America06/28/2017SE
K151298Gemini XXP-HPLNS · Traditional Dornier Medtech America07/30/2015SE

More from Dornier Medtech America

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K213772LM-9300 Plus LithotripterLNS · Traditional 01/19/2023SE
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Questions and answers

When was Lite-Med LM-9200 Elma cleared by the FDA?

Lite-Med LM-9200 Elma (K103217) received a 510(k) decision of Substantially Equivalent on September 28, 2011, 331 days after the submission was received.

What is the product code of K103217?

The FDA product code is LNS – Lithotriptor, Extracorporeal Shock-Wave, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5990.