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510(k) K200056

Catalys Precision Laser System by Amo Manufacturng USA, LLC — Product Code OOE

K200056 is an FDA 510(k) premarket notification submitted by Amo Manufacturng USA, LLC for the device "Catalys Precision Laser System". The FDA issued a decision of Substantially Equivalent on May 18, 2020. The device falls under product code OOE (Ophthalmic Femtosecond Laser), a Class II device regulated under 21 CFR 886.4390.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2020
Date Received
January 13, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmic Femtosecond Laser
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.

Other clearances for product code OOE

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  • K243896 — LenSx Laser System (8065998162) (April 28, 2025)
  • K223566 — ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (April 14, 2023)
  • K223838 — Catalys™ Precision Laser System (April 12, 2023)
  • K220259 — ALLY Adaptive Cataract Treatment System (June 9, 2022)
  • K220516 — CATALYS Precision Laser system (May 17, 2022)
  • K213559 — FEMTO LDV Z8 Femtosecond Surgical Laser (April 21, 2022)
  • K210701 — CATALYS Precision Laser System (April 7, 2021)
  • K200724 — VICTUS Femtosecond Laser Platform (September 1, 2020)
  • K182795 — LENSAR Laser System - fs 3D (LLS-fs 3D) (December 21, 2018)

FDA data resources