510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K042382Substantially Equivalent

Dual LED Lite Engine with Illumination LED Cable Coupled to a LED Lite Head

Med-General Technologies, LLC, Naples FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K042382 is the FDA 510(k) clearance record for DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD, a class II device, cleared for Med-General Technologies, LLC on under FDA product code FSY (Light, Surgical, Ceiling Mounted). FDA records list one 510(k) clearance for Med-General Technologies, LLC. As of , FDA records show no recalls naming K042382.

Clearance record

Decision date
Received
(90 days to decision)
Product code
FSY Light, Surgical, Ceiling Mounted
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Med-General Technologies, LLC 1016 Collier Center Way, Naples FL
510(k) summary
Statement
Third party review
No

Clearances, product code FSY

Trailing 12 months

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

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