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510(k) K242801

MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) by Carl Zeiss Meditec Cataract Technology, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2025
Date Received
September 17, 2024
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

Other clearances by Carl Zeiss Meditec Cataract Technology, Inc.

  • K243395 — MICOR 700 with Auto I/A (August 8, 2025)
  • K214028 — MICOR Lens Fragmentation System (September 9, 2022)
  • K222236 — miCOR System Lens Fragmentation System (August 24, 2022)
  • K200207 — xPORT S Lens Fragmentation System (October 15, 2020)
  • K200584 — xPORT 304 (miCOR) System Lens Fragmentation System (July 31, 2020)
  • K191024 — xPORT Lens Fragmentation System (August 13, 2019)

Other clearances for product code HQC

  • K250501 — System Sophi (November 14, 2025)
  • K243395 — MICOR 700 with Auto I/A (August 8, 2025)
  • 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)
  • K230858 — QUATERA 700 (July 31, 2023)
  • K214028 — MICOR Lens Fragmentation System (September 9, 2022)
  • K222236 — miCOR System Lens Fragmentation System (August 24, 2022)