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510(k) K252682

LenSx Laser System (8065000944) by Alcon Laboratories, Inc. — Product Code OOE

K252682 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "LenSx Laser System (8065000944)". The FDA issued a decision of Substantially Equivalent on September 24, 2025. The device falls under product code OOE (Ophthalmic Femtosecond Laser), a Class II device regulated under 21 CFR 886.4390. Alcon Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2025
Date Received
August 25, 2025
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 Alcon Laboratories, Inc.

  • K254052 — DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (February 13, 2026)
  • 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)
  • K222500 — AIR OPTIX COLORS (September 15, 2022)

Other clearances for product code OOE

  • 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)
  • K182795 — LENSAR Laser System - fs 3D (LLS-fs 3D) (December 21, 2018)

FDA data resources