Home / 510(k) Clearances / K102727

510(k) K102727

LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY by Lensar, Inc. — Product Code OOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2011
Date Received
September 22, 2010
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)
  • 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)

Other clearances for product code OOE

  • K252682 — LenSx Laser System (8065000944) (September 24, 2025)
  • 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)
  • K200056 — Catalys Precision Laser System (May 18, 2020)