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Lite-Med LM-9200 ELMA

by Lite-Med, Inc.

510(k) K103217

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK103217 Date28 Sep 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNS
Device Class
Class II
Regulation
21 CFR Part 876.5990
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Lite-Med LM-9200 ELMA is an extracorporeal shock-wave lithotriptor indicated for urological use. It is a device designed for the fragmentation of kidney and ureteral calculi using extracorporeal shock wave technology.

The device is supplied as a reusable system and has been determined to be substantially equivalent to predicate devices under FDA 510(k) clearance K103217. It is classified as a Class II medical device with product code LNS and regulation number 876.5990, and its use is supported by the gastroenterology and urology advisory committees.

Other devices from Lite-Med, Inc.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Lite-Med LM-9200 ELMA used for?

    The Lite-Med LM-9200 ELMA is indicated for the fragmentation of kidney and ureteral calculi using extracorporeal shock wave technology in urological procedures.

  • Is the Lite-Med LM-9200 ELMA a reusable or single-use device?

    The device is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and sterilization between procedures.

  • What regulatory pathway was used for the Lite-Med LM-9200 ELMA?

    The Lite-Med LM-9200 ELMA received FDA 510(k) clearance under K103217, demonstrating substantial equivalence to predicate devices.

  • What is the device classification and product code for the Lite-Med LM-9200 ELMA?

    The device is classified as a Class II medical device with product code LNS and regulation number 876.5990.

  • Which advisory committees supported the use of the Lite-Med LM-9200 ELMA?

    The gastroenterology and urology advisory committees supported the use of the device, as noted in its FDA submission.