CureSight

Primary DI
00199284316898
Brand
CureSight
Company
NovaSight Inc
Model
CS 100
Device description
CureSight™ FDA-cleared Digital Therapy Devices for Treatment of Amblyopia (lazy eye treatment)
Published
2025-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QQUDigital Therapy Device For Amblyopia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QQUDigital Therapy Device For AmblyopiaOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221375000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221375000CureSight-CS100Novasight , Ltd.2022-09-29QQU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199284316898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199284316898001992843168981992843168980199284316898

GMDN Terms#

Term, Definition table
TermDefinition
Dynamic visual acuity testing systemAn assembly of devices used to track changes in visual acuity during head movements primarily to quantify visual acuity loss due to vestibular pathology. The assembly typically includes a three-dimensional (3-D) integrating gyrometer (or equivalent) fastened to the patient's head, a connected personal computer used to track the patient's ability to correctly identify an image according to a specified head movement, a mounted monitor for image viewing, and operating system software. The system helps to identify patients most likely to benefit from vestibular rehabilitation exercises.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119538749
Device count
1

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007887109LuminopiaLuminopia, Inc.QQU2022-09-22
00860007887116LuminopiaLuminopia, Inc.QQU2022-09-22
00860007887123LuminopiaLuminopia, Inc.QQU2022-09-22