Home / 510(k) Clearances / K953539

510(k) K953539

DM001 DISPOSABLE PACK by American Optisurgical, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 1995
Date Received
July 28, 1995
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 American Optisurgical, Inc.

  • K101561 — TX1 TISSUE REMOVAL SYSTEM (August 27, 2010)
  • K080803 — VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551 (September 22, 2008)
  • K020527 — HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 (July 9, 2002)
  • K953538 — RM001 REUSABLE (December 26, 1995)
  • K952331 — AOI LC-40 PHACOEMULSIFIER (August 16, 1995)

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)