FDA Registration
Active
🇺🇸 United States
HYPERION MEDICAL
Reg #: 3007674911
·
FEI: 3007674911
·
Expires 2026
Products
5
Proprietary Names
3
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- HYPERION MEDICAL
- Registration Number
- 3007674911
- FEI Number
- 3007674911
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| Test, Temperature Discrimination | LQW | Class 1 | Neurology | No | 2025-03-04 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2024-11-19 |
| 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
STX4
Smart-RST
Quanta Systems
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198