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510(k) K212763

UniVit HE, UniVit UHS by Visioncare Devices, LLC — Product Code HQE

K212763 is an FDA 510(k) premarket notification submitted by Visioncare Devices, LLC for the device "UniVit HE, UniVit UHS". The FDA issued a decision of Substantially Equivalent on August 10, 2022. 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, LLC has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2022
Date Received
August 31, 2021
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, LLC

  • K120170 — PROCARE PLUS VITRECTOMY SYSTEM (May 30, 2012)
  • 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

  • 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)
  • K120170 — PROCARE PLUS VITRECTOMY SYSTEM (May 30, 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