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510(k) K093305

ENHANCED ULTRA VIT PROBE by Alcon Research, Ltd. — Product Code MLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2010
Date Received
October 22, 2009
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

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  • K110166 — CLEARCUT S SAFETY KNIFE (May 20, 2011)
  • K102860 — ALCON MULTI-PIRPOSE DISINFECTING SOLUTION (May 10, 2011)
  • K101006 — WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 (October 21, 2010)

Other clearances for product code MLZ

  • K220030 — Vista Ophthalmics Vitrectomy Probe (May 4, 2022)
  • K170520 — HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitre (March 22, 2017)
  • K081681 — VITRECTOMY CUTTER AND ACCESSORIES (October 8, 2008)