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510(k) K170576

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2017
Date Received
February 27, 2017
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)
  • 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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  • K223838 — Catalys™ Precision Laser System (April 12, 2023)
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