510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112977Substantially Equivalent

Monarch III IOL Delivery System, Monarch III C Cartridge, Monarch III Handpiece (H4)

Alcon Laboratories, Fort Worth TX / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112977 is the FDA 510(k) clearance record for MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4), a class I device, cleared for Alcon Research, Ltd. on under FDA product code MSS (Folders And Injectors, Intraocular Lens (Iol)). FDA records list 152 510(k) clearances for Alcon Laboratories, from to . As of , FDA records show one recall naming K112977.

Clearance record

Decision date
Received
(173 days to decision)
Product code
MSS Folders And Injectors, Intraocular Lens (Iol)
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 PDF
Third party review
No

Clearances, product code MSS

Trailing 12 months
1 clearance under product code MSS in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MSS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260