FDA UDI
In Commercial Distribution
🇺🇸 United States
CureSight
DI: 00199284316898
·
Model: CS 100
·
NovaSight Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CureSight
- Primary DI
- 00199284316898
- Version / Model
- CS 100
- Company Name
- NovaSight Inc
- Labeler DUNS
- 119538749
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-25
- Public Version
- 1
- Public Version Date
- 2025-07-03
- Public Version Status
- New
- Public Device Record Key
- fd267930-a862-41b8-a3a6-4edb1570123a
Device Description
CureSight™ FDA-cleared Digital Therapy Devices for Treatment of Amblyopia (lazy eye treatment)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QQU | Digital Therapy Device For Amblyopia | Ophthalmic | 886.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45584 | Dynamic visual acuity testing system | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00199284316898 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221375 | 000 |