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510(k) K202221

VX650 by Luneau Technology Operations — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2021
Date Received
August 6, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

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