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CureSight

FDA UDI

Class II (US FDA UDI)

by NovaSight Inc

Identity

Trade Name
CureSight FDA UDI
Generic Name
Dynamic visual acuity testing system FDA UDI
Device Name
CureSight™ FDA-cleared Digital Therapy Devices for Treatment of Amblyopia (lazy eye treatment) FDA UDI
Model / Reference
CS 100 FDA UDI
Description
CureSight™ FDA-cleared Digital Therapy Devices for Treatment of Amblyopia (lazy eye treatment) FDA UDI

Identifiers

Primary DI / UDI-DI
00199284316898 FDA UDI
510(k) Number
K221375 FDA UDI
FDA Product Code
QQU FDA UDI
GMDN Term
Dynamic visual acuity testing system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.5500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dynamic visual acuity testing system

CureSight by NovaSight Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dynamic visual acuity testing system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
NovaSight Inc

Sources (1)

  • FDA UDI fd267930-a862-41b8-a3a6-4edb1570123a 34 fields · synced May 30, 2026