510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904348Substantially Equivalent

Cui Feathered Silicone Malar

Cui Corp., Santa Barbara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904348 is the FDA 510(k) clearance record for CUI FEATHERED SILICONE MALAR, a class II device, cleared for Cui Corp. on under FDA product code LZK (Implant, Malar). FDA records list 7 510(k) clearances for Cui Corp., from to . As of , FDA records show no recalls naming K904348.

Clearance record

Decision date
Received
(63 days to decision)
Product code
LZK Implant, Malar
Regulation
21 CFR 878.3550
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cui Corp. P.O. Box 40288, Santa Barbara CA
Third party review
No

Clearances, product code LZK

Trailing 12 months

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

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