FDA UDI
In Commercial Distribution
🇺🇸 United States
ExoLens
DI: 04719889764267
·
Model: B25HJC-0A12ON0250AAB-LDG19
·
INNOVA VISION INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- ExoLens
- Primary DI
- 04719889764267
- Version / Model
- B25HJC-0A12ON0250AAB-LDG19
- Company Name
- INNOVA VISION INC.
- Labeler DUNS
- 658030747
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2025-10-31
- Public Version
- 1
- Public Version Date
- 2025-11-10
- Public Version Status
- New
- Public Device Record Key
- 84f07d2d-6a37-4525-a5a4-7c18afb2dfcf
Device Description
Soft (Hydrophilic) Contact Lens
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | 886.5925 | 2 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | 886.5925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47841 | Soft corrective contact lens, daily-disposable | A soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be discarded each day after removal. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04719889753674 | GS1 | ||||
| Primary | 04719889764267 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213119 | 000 |