510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K050923Substantially Equivalent

Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction Ablator

Conmed Linvatec, Largo FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050923 is the FDA 510(k) clearance record for LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR, a class II device, cleared for Conmed Linvatec on under FDA product code JOS (Electrode, Electrosurgical). FDA records list 21 510(k) clearances for Conmed Linvatec, from to . As of , FDA records show one recall naming K050923.

Clearance record

Decision date
Received
(35 days to decision)
Product code
JOS Electrode, Electrosurgical
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Conmed Linvatec 11311 Concept Blvd., Largo FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOS

Trailing 12 months

FDA records hold no clearances under product code JOS in the trailing twelve months.

FDA records show no clearances under product code JOS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JOS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260