Luminopia One— 510(k) K221659

Substantially Equivalent

Luminopia, Inc.

FDA 510(k) clearance K221659 for Luminopia One, Substantially Equivalent on 2022-11-04. Applicant: Luminopia, Inc.. Device class: 2.

Clearance details

Applicant
Luminopia, Inc.
Product code
Code QQU
Device class
Class 2
Regulation
21 CFR 886.5500
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cambridge, MA, US
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