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510(k) K120170

PROCARE PLUS VITRECTOMY SYSTEM by Visioncare Devices, Inc. — Product Code HQE

K120170 is an FDA 510(k) premarket notification submitted by Visioncare Devices, Inc. for the device "PROCARE PLUS VITRECTOMY SYSTEM". The FDA issued a decision of Substantially Equivalent on May 30, 2012. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Visioncare Devices, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2012
Date Received
January 19, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances by Visioncare Devices, Inc.

  • K212763 — UniVit HE, UniVit UHS (August 10, 2022)
  • K023939 — VELOCITY ADVANTAGE (April 17, 2003)
  • K971064 — BAYERS BIMANUAL I/A HANDPIECES (June 9, 1997)
  • K940746 — VIT CUTTER MODEL 94 (June 6, 1994)
  • K904909 — I/A VITROPHAGE MODEL YPR 2001 (January 28, 1991)

Other clearances for product code HQE

  • K212763 — UniVit HE, UniVit UHS (August 10, 2022)
  • K170183 — Cetus system, Cetus probe (September 27, 2017)
  • K153168 — Bi-Blade Vitrectomy Cutter (April 29, 2016)
  • K141065 — CONSTELLATION VISION SYSTEM (August 22, 2014)
  • K121675 — VERSAVIT (June 21, 2012)
  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (April 8, 2011)
  • K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTER (November 4, 2003)
  • K030948 — VMATE MODEL VMM1000 (June 17, 2003)
  • K023939 — VELOCITY ADVANTAGE (April 17, 2003)
  • K020911 — MID LABS AUTONOMOUS VIT ENHANCER (AVE) (April 29, 2002)

FDA data resources