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510(k) K151636

AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control by Abbott Medical Optics, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2015
Date Received
June 17, 2015
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 Abbott Medical Optics, Inc.

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  • K133115 — COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGL (February 27, 2014)
  • K121721 — LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) (October 15, 2012)
  • K113151 — IFS LASER SYSTEM (March 8, 2012)
  • K111446 — SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM (December 21, 2011)
  • K111882 — LAMINAR FLOW PHACO TIPS (November 7, 2011)
  • K111697 — AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM (September 27, 2011)

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