FDA Registration
Active
🇺🇸 United States
miraDry, Inc.
Reg #: 3008082710
·
FEI: 3008082710
·
Expires 2026
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- miraDry, Inc.
- Registration Number
- 3008082710
- FEI Number
- 3008082710
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 721 Charcot Ave
- City
- San Jose
- State
- CA
- ZIP
- 95131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150419
Owner / Operator
- Firm Name
- miraDry Inc.
- Operator Number
- 10082621
- Address
- 721 Charcot Ave
- City
- San Jose
- State
- CA
- Postal Code
- 95131
- Country
- US
- Correspondent
- Cynthia Kada
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Ablation, Microwave And Accessories | NEY | Class 2 | General, Plastic Surgery | No | 2021-08-26 |
| Instrument For Treatment Of Hyperhidrosis | OUB | Class 2 | General, Plastic Surgery | No | 2021-08-26 |
| System, Microwave, Hair Removal | MWY | Class 2 | General, Plastic Surgery | No | 2021-08-26 |
Proprietary Names
miraDry System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device