Home / 510(k) Clearances / K060366

510(k) K060366

THE AMO OPHTHALMIC SURGICAL SYSTEM by Advanced Medical Optics, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2006
Date Received
February 13, 2006
Clearance Type
Abbreviated
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 Advanced Medical Optics, Inc.

  • K081681 — VITRECTOMY CUTTER AND ACCESSORIES (October 8, 2008)
  • K081545 — ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 (October 2, 2008)
  • K042562 — LENS PLUS REWETTING DROPS (July 29, 2005)
  • K050648 — SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK (April 5, 2005)
  • K040839 — COMPLETE BLINK-N-CLEAN LENS DROPS (October 19, 2004)
  • K032030 — BLINK CL LUBRICANT EYE DROPS (September 25, 2003)
  • K030092 — COMPLETE BRAND MULTI-PURPOSE SOLUTION (April 4, 2003)

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)