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510(k) K191650

LEGION System by Alcon Research, LLC — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2019
Date Received
June 20, 2019
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

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  • K101006 — WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 (October 21, 2010)
  • K093305 — ENHANCED ULTRA VIT PROBE (April 2, 2010)

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