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510(k) K090633

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2010
Date Received
March 9, 2009
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.

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  • K173346 — LENSAR Laser System - fs 3D (LLS-fs 3D) (March 2, 2018)
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  • 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)

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