510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081477Substantially Equivalent

Luxtec Mlx Light Source

Integra Luxtec, Inc., West Boylston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K081477 is the FDA 510(k) clearance record for LUXTEC MLX LIGHT SOURCE, a class II device, cleared for Integra Luxtec, Inc. on under FDA product code FCW (Light Source, Fiberoptic, Routine). FDA records list one 510(k) clearance for Integra Luxtec, Inc. As of , FDA records show 4 recalls naming K081477.

Clearance record

Decision date
Received
(22 days to decision)
Product code
FCW Light Source, Fiberoptic, Routine
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Integra Luxtec, Inc. 99 Hartwell St., West Boylston MA
510(k) summary
Statement
Third party review
No

Clearances, product code FCW

Trailing 12 months

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

FDA records show no clearances under product code FCW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCW, 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