VX130 Ophthalmic Diagnostic Device— 510(k) K162067

Substantially Equivalent

Luneau Sas

FDA 510(k) clearance K162067 for VX130 Ophthalmic Diagnostic Device, Substantially Equivalent on 2017-04-24. Applicant: Luneau Sas. Device class: 2.

Clearance details

Applicant: Luneau Sas
Product code: Code HKX
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2016-07-26
Decision date: 2017-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Prunay Le Gillon, FR

Download summary PDF View on FDA.gov ↗

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