FDA Registration
Active
🇺🇸 United States
ZOOMAX (USA) INC.
Reg #: 3014656174
·
FEI: 3014656174
·
Expires 2026
Products
4
Proprietary Names
18
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ZOOMAX (USA) INC.
- Registration Number
- 3014656174
- FEI Number
- 3014656174
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6 Liberty Square #2572
- City
- Boston
- State
- MA
- ZIP
- 02109
- Country
- US
Owner / Operator
- Firm Name
- Zoomax (USA) Inc.
- Operator Number
- 10058885
- Address
- 6 Liberty Square #2572
- City
- Boston
- State
- MA
- Postal Code
- 02109
- Country
- US
- Correspondent
- Stella Shen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spectacle, Magnifying | HOI | Class 1 | Ophthalmic | No | 2018-11-06 |
| Magnifier, Hand-Held, Low-Vision | HJF | Class 1 | Ophthalmic | No | 2018-11-06 |
| Aid, Vision, Electronic, Battery-Powered | HPG | Class 1 | Ophthalmic | No | 2019-04-23 |
| System, Reading, Television, Closed-Circuit | HJG | Class 1 | Ophthalmic | No | 2018-12-07 |
Proprietary Names
Acesight
Acesight S
Acesight VR
M5 HD Plus
Butterfly
Snow 7 HD Plus
Snow 4.3
Snow 10 Pro
Luna S
Snow 12
Luna 8
Luna 6
ClouClip M2
ClouClip P2
Panda HD
Panda SD
Aurora HD
Luna HD 24 Pro
Establishment Types
Repack or Relabel Medical Device