510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864385Substantially Equivalent

Luxtec Light Sources

Luxtec Corp., Sturbridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864385 is the FDA 510(k) clearance record for LUXTEC LIGHT SOURCES, a class II device, cleared for Luxtec Corp. on under FDA product code FCW (Light Source, Fiberoptic, Routine). FDA records list 15 510(k) clearances for Luxtec Corp., from to . As of , FDA records show one recall naming K864385.

Clearance record

Decision date
Received
(69 days to decision)
Product code
FCW Light Source, Fiberoptic, Routine
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Luxtec Corp. P.O. Box 225, Rte. 20/49, Sturbridge MA
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