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510(k) K173660

LenSx Laser System by Alcon Laboratories, Inc. — Product Code OOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2018
Date Received
November 29, 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 Alcon Laboratories, Inc.

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  • K252682 — LenSx Laser System (8065000944) (September 24, 2025)
  • K243896 — LenSx Laser System (8065998162) (April 28, 2025)
  • K243909 — Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astig (January 13, 2025)
  • K242184 — Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (806 (December 4, 2024)
  • K233876 — UNITY VCS (8065000296); UNITY CS (8065000297) (June 21, 2024)
  • K233902 — Centurion™ Vision System (Active Sentry™) (8065753057) (January 10, 2024)
  • K233856 — Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL3 (December 29, 2023)
  • K232921 — DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTA (November 16, 2023)
  • K230785 — Precision1, Precision1 for Astigmatism (April 20, 2023)

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)