Home / 510(k) Clearances / K950799

510(k) K950799

PRO-VIT by M. Imonti and Associates Inc., — Product Code HQE

K950799 is an FDA 510(k) premarket notification submitted by M. Imonti and Associates Inc., for the device "PRO-VIT". The FDA issued a decision of Substantially Equivalent on April 28, 1995. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. M. Imonti and Associates Inc., has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1995
Date Received
February 21, 1995
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 M. Imonti and Associates Inc.,

  • K950800 — PRO-PAK FOR OMS DIPLOMATE (May 22, 1995)
  • K933627 — PHACOFRAGMENTOR TIP (January 25, 1994)
  • 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 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)
  • 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)

FDA data resources