FDA Registration
Active
🇺🇸 United States
ZX2 Laser System
Reg #: 3011765635
·
FEI: 3011765635
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- LZR7, INC.
- Registration Number
- 3011765635
- FEI Number
- 3011765635
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 618 Fish Creek Thoroughfare, Ste. 100
- City
- Montgomery
- State
- TX
- ZIP
- 77316
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150466
Owner / Operator
- Firm Name
- LZR7, Inc.
- Operator Number
- 10049713
- Address
- 9069 Stone Oak Drive
- City
- Montgomery
- State
- TX
- Postal Code
- 77316
- Country
- US
- Correspondent
- Randy Rinkleib
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2015-07-15 |
Proprietary Names
ZX2 Laser System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility