FDA Registration
Active
🇺🇸 United States
Quanta Systems
Reg #: 3007674911
·
FEI: 3007674911
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- HYPERION MEDICAL
- Registration Number
- 3007674911
- FEI Number
- 3007674911
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15932 MIDWAY RD
- City
- ADDISON
- State
- TX
- ZIP
- 75001
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151629
Owner / Operator
- Firm Name
- Hyperion Medical
- Operator Number
- 10033629
- Address
- 15914 Midway Road
- City
- Addison
- State
- TX
- Postal Code
- 75001
- Country
- US
- Correspondent
- Scott A Day
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | PDZ | Class 2 | General, Plastic Surgery | No | 2015-11-06 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2015-11-06 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2015-11-06 |
Proprietary Names
Quanta Systems
Establishment Types
Repack or Relabel Medical Device