FDA Registration
Active
🇺🇸 United States
Dermal Cooling System
Reg #: 3012157621
·
FEI: 3012157621
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- GENER8
- Registration Number
- 3012157621
- FEI Number
- 3012157621
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2560 Junction Avenue
- City
- San Jose
- State
- CA
- ZIP
- 95134
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213294
Owner / Operator
- Firm Name
- Gener8
- Operator Number
- 10059512
- Address
- 2560 Junction Avenue
- City
- San Jose
- State
- CA
- Postal Code
- 95134
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Brush, Dermabrasion, Manual | GED | Class 1 | General, Plastic Surgery | No | 2023-06-29 |
| Contact Cooling For Skin Lesion Pain Relief | QPZ | Class 2 | General, Plastic Surgery | No | 2023-06-29 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2023-06-29 |
Proprietary Names
Dermal Cooling System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)