510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894765Substantially Equivalent

Sharplan Smoke Evacuation Unit, Model 100

Laser Industries, Ltd., Allendale NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894765 is the FDA 510(k) clearance record for SHARPLAN SMOKE EVACUATION UNIT, MODEL 100, a class II device, cleared for Laser Industries , Ltd. on under FDA product code FYD (Apparatus, Exhaust, Surgical). FDA records list 20 510(k) clearances for Laser Industries , Ltd., from to . As of , FDA records show no recalls naming K894765.

Clearance record

Decision date
Received
(64 days to decision)
Product code
FYD Apparatus, Exhaust, Surgical
Regulation
21 CFR 878.5070
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Laser Industries , Ltd. 1 Pearl Ct., Allendale NJ
Third party review
No

Clearances, product code FYD

Trailing 12 months

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

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