CureSight

GUDID 00199284316898

CureSight™ FDA-cleared Digital Therapy Devices for Treatment of Amblyopia (lazy eye treatment)

NovaSight Inc

Dynamic visual acuity testing system

• Primary Device ID: 00199284316898
• NIH Device Record Key: fd267930-a862-41b8-a3a6-4edb1570123a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CureSight
• Version Model Number: CS 100
• Company DUNS: 119538749
• Company Name: NovaSight Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199284316898 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221375

FDA Product Code

• QQU: Digital Therapy Device For Amblyopia

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-03
• Device Publish Date: 2025-06-25