FDA Registration
Active
🇺🇸 United States
Zutta LED Mask
Reg #: 3020659203
·
FEI: 3020659203
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Passiflora inc.
- Registration Number
- 3020659203
- FEI Number
- 3020659203
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- Passiflora Inc., 1000 5th Street Suite 200
- City
- Miami Beach
- State
- FL
- ZIP
- 33139
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202390
Owner / Operator
- Firm Name
- Passiflora Inc
- Operator Number
- 10061598
- Address
- Passiflora Inc., 1000 5th Street Suite 200
- City
- Miami Beach
- State
- FL
- Postal Code
- 33139
- Country
- US
- Correspondent
- Moran S Tabak
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2022-01-14 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2022-01-14 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2022-01-14 |
Proprietary Names
Zutta LED Mask
Establishment Types
Repack or Relabel Medical Device