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510(k) K143010

LENSAR Laser System - fs 3D by Lensar, Inc. — Product Code OOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2015
Date Received
October 20, 2014
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.

  • K220259 — ALLY Adaptive Cataract Treatment System (June 9, 2022)
  • 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)
  • 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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  • 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)
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  • K210701 — CATALYS Precision Laser System (April 7, 2021)
  • K200724 — VICTUS Femtosecond Laser Platform (September 1, 2020)
  • K200056 — Catalys Precision Laser System (May 18, 2020)