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510(k) K213772

LM-9300 Plus Lithotripter by Lite-Med, Inc. — Product Code LNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2023
Date Received
December 2, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Extracorporeal Shock-Wave, Urological
Device Class
Class II
Regulation Number
876.5990
Review Panel
GU
Submission Type

Other clearances by Lite-Med, Inc.

  • K142561 — LM-9300 ELMA Lithotripter (March 20, 2015)
  • K103217 — LITE-MED LM-9200 ELMA (September 28, 2011)

Other clearances for product code LNS

  • K252913 — Break Wave (January 12, 2026)
  • K242922 — Extracorporeal Shock Wave Lithotripter (U200) (June 18, 2025)
  • K221903 — Delta III Pro (February 22, 2023)
  • K201001 — Modulith SLX-F2 (March 30, 2021)
  • K201074 — Delta III Lithotripter (September 3, 2020)
  • K172084 — Delta III Lithotripter (August 8, 2017)
  • K170122 — Delta III Lithotripter (June 28, 2017)
  • K151298 — Gemini XXP-HP (July 30, 2015)
  • K142561 — LM-9300 ELMA Lithotripter (March 20, 2015)
  • K131817 — EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (September 26, 2014)