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
K854159Substantially Equivalent

Ellipti-Punch

Alcon Laboratories, Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854159 is the FDA 510(k) clearance record for ELLIPTI-PUNCH, a class II device, cleared for Alcon Laboratories on under FDA product code FZI (Apparatus, Air Handling, Enclosure). FDA records list 152 510(k) clearances for Alcon Laboratories, from to . As of , FDA records show no recalls naming K854159.

Clearance record

Decision date
Received
(35 days to decision)
Product code
FZI Apparatus, Air Handling, Enclosure
Regulation
21 CFR 878.5070
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Alcon Laboratories 6201 S. Fwy. R7-14, Fort Worth TX
Third party review
No

Clearances, product code FZI

Trailing 12 months

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

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