510(K) CLEARANCES 63 ▲12RECALLS POSTED 17 ▼8CLASS I 1PMA DECISIONS 48 ▼2WEEK ENDING / FDA DATA AS OF
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K992050Substantially Equivalent

Lumenon Xenon Light Source

Biomet Microfixation, Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992050 is the FDA 510(k) clearance record for LUMENON XENON LIGHT SOURCE, a class II device, cleared for Walter Lorenz Surgical, Inc. on under FDA product code GCT (Light Source, Endoscope, Xenon Arc). FDA records list 86 510(k) clearances for BIOMET MICROFIXATION, from to . As of , FDA records show no recalls naming K992050.

Clearance record

Decision date
Received
(89 days to decision)
Product code
GCT Light Source, Endoscope, Xenon Arc
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Walter Lorenz Surgical, Inc. 1520 Tradeport Dr., Jacksonville FL
510(k) summary
Summary
Third party review
No

Clearances, product code GCT

Trailing 12 months

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

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