FDA Registration
Active
🇺🇸 United States
D-Laser 16, D-Laser Blue, LX 16, LX16 Plus
Reg #: 1419489
·
FEI: 1419489
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- NORDENT MFG., INC.
- Registration Number
- 1419489
- FEI Number
- 1419489
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 610 BONNIE LANE
- City
- ELK GROVE VILLAGE
- State
- IL
- ZIP
- 60007
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210367
Owner / Operator
- Firm Name
- NORDENT MFG., INC.
- Operator Number
- 1419489
- Address
- 610 BONNIE LANE, --
- City
- Elk Grove Village
- State
- IL
- Postal Code
- 60007
- Country
- US
- Correspondent
- Anant - Shah
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2025-03-20 |
| Laser, Dental, Soft Tissue | NVK | Class 2 | General, Plastic Surgery | No | 2025-03-20 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2025-03-20 |
Proprietary Names
D-Laser 16, D-Laser Blue, LX 16, LX16 Plus
Establishment Types
Repack or Relabel Medical Device