510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K021775Substantially Equivalent

Ltfs230

Varian Medical Systems, Inc., Marietta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021775 is the FDA 510(k) clearance record for LTFS230, a class II device, cleared for Healthtronics, Inc. on under FDA product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological). FDA records list 238 510(k) clearances for Varian Medical Systems, Inc., from to . As of , FDA records show no recalls naming K021775.

Clearance record

Decision date
Received
(208 days to decision)
Product code
LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Regulation
21 CFR 876.5990
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Healthtronics, Inc. 1841 W. Oak Pkwy., Marietta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LNS

Trailing 12 months
2 clearances under product code LNS in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LNS, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260