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510(k) K081681

VITRECTOMY CUTTER AND ACCESSORIES by Advanced Medical Optics, Inc. — Product Code MLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2008
Date Received
June 17, 2008
Clearance Type
Abbreviated
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 by Advanced Medical Optics, Inc.

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  • K042562 — LENS PLUS REWETTING DROPS (July 29, 2005)
  • K050648 — SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK (April 5, 2005)
  • K040839 — COMPLETE BLINK-N-CLEAN LENS DROPS (October 19, 2004)
  • K032030 — BLINK CL LUBRICANT EYE DROPS (September 25, 2003)
  • K030092 — COMPLETE BRAND MULTI-PURPOSE SOLUTION (April 4, 2003)

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)
  • K093305 — ENHANCED ULTRA VIT PROBE (April 2, 2010)