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510(k) K220259

ALLY Adaptive Cataract Treatment System by Lensar, Inc. — Product Code OOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2022
Date Received
January 31, 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 Lensar, Inc.

  • K182795 — LENSAR Laser System - fs 3D (LLS-fs 3D) (December 21, 2018)
  • K181430 — LENSAR Laser System - fs 3D (LLS-fs 3D) (August 9, 2018)
  • K173346 — LENSAR Laser System - fs 3D (LLS-fs 3D) (March 2, 2018)
  • K171337 — LENSAR Laser System – fs 3D (LLS-fs 3D) (August 10, 2017)
  • K170576 — LENSAR Laser System - fs 3D (LLS-fs 3D) (May 5, 2017)
  • K152453 — LENSAR Laser System - fs 3D (LLS-fs 3D) (October 15, 2015)
  • K143010 — LENSAR Laser System - fs 3D (March 20, 2015)
  • K123859 — TBD (March 27, 2013)
  • K122829 — LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS (December 3, 2012)
  • K120214 — TBD (June 8, 2012)

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  • K223566 — ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (April 14, 2023)
  • K223838 — Catalys™ Precision Laser System (April 12, 2023)
  • 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)
  • K200056 — Catalys Precision Laser System (May 18, 2020)
  • K182795 — LENSAR Laser System - fs 3D (LLS-fs 3D) (December 21, 2018)