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510(k) K141065

CONSTELLATION VISION SYSTEM by Alcon Research, Ltd. — Product Code HQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2014
Date Received
April 24, 2014
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

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

Other clearances for product code HQE

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  • 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)
  • K020911 — MID LABS AUTONOMOUS VIT ENHANCER (AVE) (April 29, 2002)