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510(k) K230858

QUATERA 700 by Carl Zeiss Meditec, AG — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2023
Date Received
March 29, 2023
Clearance Type
Traditional
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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  • 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)
  • K233902 — Centurion™ Vision System (Active Sentry™) (8065753057) (January 10, 2024)
  • K214028 — MICOR Lens Fragmentation System (September 9, 2022)
  • K222236 — miCOR System Lens Fragmentation System (August 24, 2022)