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510(k) K152453

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2015
Date Received
August 28, 2015
Clearance Type
Special
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)
  • 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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