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
K864381Substantially Equivalent

Luxtec Videolux 20/20 Camera Headlight System

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

K864381 is the FDA 510(k) clearance record for LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM, a class I device, cleared for Luxtec Corp. on under FDA product code FWC (Camera, Television, Surgical, With Audio). FDA records list 15 510(k) clearances for Luxtec Corp., from to . As of , FDA records show no recalls naming K864381.

Clearance record

Decision date
Received
(34 days to decision)
Product code
FWC Camera, Television, Surgical, With Audio
Regulation
21 CFR 878.4160
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Luxtec Corp. P.O. Box 225, Rte. 20/49, Sturbridge MA
Third party review
No

Clearances, product code FWC

Trailing 12 months

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

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