Home / 510(k) Clearances / K933627

510(k) K933627

PHACOFRAGMENTOR TIP by M. Imonti and Associates Inc., — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1994
Date Received
July 27, 1993
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 M. Imonti and Associates Inc.,

  • K950800 — PRO-PAK FOR OMS DIPLOMATE (May 22, 1995)
  • K950799 — PRO-VIT (April 28, 1995)
  • K933503 — PRO-PHACO HANDPIECE (January 6, 1994)
  • K924551 — ENDO TRACHEA TUBE FIXATION (December 8, 1992)
  • K905766 — DRAINAGE TUBE RESTRAINT/WOUND COVER (March 6, 1991)

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)