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510(k) K212241

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2022
Date Received
July 19, 2021
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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  • K233876 — UNITY VCS (8065000296); UNITY CS (8065000297) (June 21, 2024)
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  • K233902 — Centurion™ Vision System (Active Sentry™) (8065753057) (January 10, 2024)
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