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510(k) K221375

Device
CureSight-CS100
Applicant
NovaSight Ltd.
510(k) number
K221375
Product code
QQU  
Decision
Substantially Equivalent (SESE)
Decision date
2022-09-29
Date received
2022-05-12
Regulation
886.5500
Classification name
Digital Therapy Device For Amblyopia
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ran Yam
Address
1 Hayarden St. Airport City IL 7019801 7019801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QQU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243819LuminopiaLuminopia, Inc.2025-04-09
K233720LuminopiaLuminopia, Inc.2024-08-08
K221659Luminopia OneLuminopia, Inc.2022-11-04
DEN210005Luminopia OneLuminopia, Inc.2021-10-20

Legacy Summary#

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FDA Review#

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