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510(k) K220030

Vista Ophthalmics Vitrectomy Probe by Vista Ophthalmics, LLC — Product Code MLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2022
Date Received
January 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vitrectomy, Instrument Cutter
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances for product code MLZ

  • K170520 — HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitre (March 22, 2017)
  • K093305 — ENHANCED ULTRA VIT PROBE (April 2, 2010)
  • K081681 — VITRECTOMY CUTTER AND ACCESSORIES (October 8, 2008)