Home / 510(k) Clearances / K233902

510(k) K233902

Centurion™ Vision System (Active Sentry™) (8065753057) by Alcon Laboratories, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2024
Date Received
December 11, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

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  • K230785 — Precision1, Precision1 for Astigmatism (April 20, 2023)
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Other clearances for product code HQC

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  • K240169 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) (July 26, 2024)
  • K233398 — Faros Surgical System (June 27, 2024)
  • K233876 — UNITY VCS (8065000296); UNITY CS (8065000297) (June 21, 2024)
  • K232084 — Stellaris Elite vision enhancement system (February 26, 2024)
  • K230858 — QUATERA 700 (July 31, 2023)
  • K214028 — MICOR Lens Fragmentation System (September 9, 2022)
  • K222236 — miCOR System Lens Fragmentation System (August 24, 2022)