Home / 510(k) Clearances / K974469

510(k) K974469

MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL by Mentor Corp. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1998
Date Received
November 26, 1997
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 Mentor Corp.

  • K130813 — MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TI (April 11, 2013)
  • K053414 — MENTOR NOVASILK MESH (December 27, 2005)
  • K050008 — MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER (June 3, 2005)
  • K042851 — MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT (November 9, 2004)
  • K040959 — MENTOR GENESIS PENILE PROSTHESIS (October 29, 2004)
  • K031767 — MENTOR OBTAPE TRANS-OBTURATOR TAPE (July 17, 2003)
  • K011493 — MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRA (October 1, 2002)
  • K011500 — MENTOR CONTOUR PROFILE TISSUE EXPANDER (December 3, 2001)
  • K004005 — MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENES (October 12, 2001)
  • K010709 — MENTOR STERILE SALINE MAMMARY VOLUME SIZERS (April 23, 2001)

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)