Home / 510(k) Clearances / K142877

510(k) K142877

EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) by Dutch Ophthalmic Research Center International BV — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2015
Date Received
October 1, 2014
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 Dutch Ophthalmic Research Center International BV

  • K160591 — D.O.R.C. Disposable Cryo Probe (January 23, 2017)
  • K081877 — ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS (January 5, 2009)
  • K062895 — XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII (October 13, 2006)

Other clearances for product code HQC

  • K250501 — System Sophi (November 14, 2025)
  • K243395 — MICOR 700 with Auto I/A (August 8, 2025)
  • K242801 — MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-5062 (June 11, 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)