510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011794Substantially Equivalent

Xltek LED Goggles, Model LED-01

Excel Tech., Ltd., Oakville, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011794 is the FDA 510(k) clearance record for XLTEK LED GOGGLES, MODEL LED-01, a class II device, cleared for Excel Tech. , Ltd. on under FDA product code GWE (Stimulator, Photic, Evoked Response). FDA records list 58 510(k) clearances for Excel Tech. , Ltd., from to . As of , FDA records show no recalls naming K011794.

Clearance record

Decision date
Received
(115 days to decision)
Product code
GWE Stimulator, Photic, Evoked Response
Regulation
21 CFR 882.1890
Device class
Class II
Review panel
Neurology
Applicant
Excel Tech. , Ltd. 2568 Bristol Cir., Oakville, CA
510(k) summary
Summary
Third party review
No

Clearances, product code GWE

Trailing 12 months

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

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