510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200056Substantially Equivalent

Catalys Precision Laser System

Amo Manufacturng USA, LLC, Milpitas CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200056 is the FDA 510(k) clearance record for Catalys Precision Laser System, a class II device, cleared for Amo Manufacturng USA, LLC on under FDA product code OOE (Ophthalmic Femtosecond Laser). FDA's definition for product code OOE reads: "Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery". FDA records list one 510(k) clearance for Amo Manufacturng USA, LLC. As of , FDA records show no recalls naming K200056.

Clearance record

Decision date
Received
(126 days to decision)
Product code
OOE Ophthalmic Femtosecond Laser
Regulation
21 CFR 886.4390
Device class
Class II
Review panel
Ophthalmic
Applicant
Amo Manufacturng USA, LLC 510 Cottonwood Dr., Milpitas CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OOE

Trailing 12 months

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

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