FDA Registration
Active
🇺🇸 United States
PolyDev Soft Contact Lenses
Reg #: 3005184723
·
FEI: 3005184723
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Acucon
- Registration Number
- 3005184723
- FEI Number
- 3005184723
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 7455 16th Street E Suite 108
- City
- SARASOTA
- State
- FL
- ZIP
- 34243
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161931
Owner / Operator
- Firm Name
- ACUCON, LLC
- Operator Number
- 10086820
- Address
- 7455 16th Street E Suite 108
- City
- Sarasota
- State
- FL
- Postal Code
- 34243
- Country
- US
- Correspondent
- Michelle Perkins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lenses, Soft Contact, Daily Wear | LPL | Class 2 | Ophthalmic | No | 2023-01-25 |
Proprietary Names
PolyDev Soft Contact Lenses
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility