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510(k) K220516

CATALYS Precision Laser system by Amo Manufacturing USA, LLC — Product Code OOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2022
Date Received
February 23, 2022
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 by Amo Manufacturing USA, LLC

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  • K172002 — Catalys Precision Laser System (August 25, 2017)
  • K141852 — IFS ADVANCED FEMTOSECOND LASER SYSTEM (January 6, 2015)

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  • 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)
  • 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)
  • K200056 — Catalys Precision Laser System (May 18, 2020)
  • K182795 — LENSAR Laser System - fs 3D (LLS-fs 3D) (December 21, 2018)