FDA Registration
Active
🇺🇸 United States
SHINYEYES INC.
Reg #: 3012719596
·
FEI: 3012719596
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- SHINYEYES INC.
- Registration Number
- 3012719596
- FEI Number
- 3012719596
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 178 S Euclid Ave Unit 302
- City
- Pasadena
- State
- CA
- ZIP
- 91101
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161100
- PMA Number
- P240045
Owner / Operator
- Firm Name
- Shinyeyes Corp.
- Operator Number
- 10052566
- Address
- 178 S Euclid Ave, Unit 302
- City
- Pasadena
- State
- CA
- Postal Code
- 91101
- Country
- US
- Correspondent
- Hsiao Ching Tung
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lens, Contact (Other Material) - Daily | HQD | Class 2 | Ophthalmic | No | 2023-10-30 |
| Lenses, Soft Contact, Daily Wear | LPL | Class 2 | Ophthalmic | No | 2024-12-17 |
| Lens, Contact, (Disposable) | MVN | Class 2 | Ophthalmic | No | 2024-12-17 |
| Lens, Contact, Orthokeratology, Overnight | NUU | Class 3 | Ophthalmic | No | 2026-04-24 |
| Lens, Contact (Orthokeratology) | MUW | Class 2 | Ophthalmic | No | 2023-10-30 |
Proprietary Names
GOV Lens
PVS SoftOK SiHy 1 Day Contact Lens
ArtMost SoftOK Multifocal Soft Contact Lenses
GOV Overnight Ortho-K Lens
RG5 Overnight Ortho-K Lens
ArtMost SoftOK
Establishment Types
Complaint File Establishment per 21 CFR 820.198