510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001157Substantially Equivalent

Monarch II IOL Delivery System

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

K001157 is the FDA 510(k) clearance record for MONARCH II IOL DELIVERY SYSTEM, a class I device, cleared for Alcon Research, Ltd. on under FDA product code KYB (Lens, Guide, Intraocular). FDA records list 152 510(k) clearances for Alcon Laboratories, from to . As of , FDA records show one recall naming K001157.

Clearance record

Decision date
Received
(78 days to decision)
Product code
KYB Lens, Guide, Intraocular
Regulation
21 CFR 886.4300
Device class
Class I
Review panel
Ophthalmic
Applicant
Alcon Research, Ltd. 6201 S. Fwy., Fort Worth TX
510(k) summary
Summary
Third party review
No

Clearances, product code KYB

Trailing 12 months

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

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