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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vitrectomy, Instrument Cutter
510(k) Number K170520
Device Name HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
Applicant
Alcon Research, Ltd.
20511 Lake Forest Dr.
Lake Forest,  CA  92630
Applicant Contact Karen Mudd
Correspondent
Alcon Research, Ltd.
20511 Lake Forest Dr.
Lake Forest,  CA  92630
Correspondent Contact Karen Mudd
Regulation Number886.4150
Classification Product Code
MLZ  
Subsequent Product Code
HQE  
Date Received02/22/2017
Decision Date 03/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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