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510(k) K112425

INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE by Alcon Manufacturing, Ltd. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2011
Date Received
August 23, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

Other clearances by Alcon Manufacturing, Ltd.

  • K120912 — INFINITI(R) VISION SYSTEM (June 15, 2012)
  • K101774 — MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE ( (October 13, 2011)
  • K101285 — CONSTELLATION VISION SYSTEM (November 12, 2010)
  • K093210 — AQUALASE CAPSULE WASH TIP (March 4, 2010)
  • K063155 — MONARCH III IOL DELIVERY SYSTEM (March 27, 2007)

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