FDA Registration
Active
🇺🇸 United States
iLIGHT Pro, Ilight Pro Premier
Reg #: 3005855240
·
FEI: 3005855240
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Spectrum Brands, Inc. (a Delaware Corporation)
- Registration Number
- 3005855240
- FEI Number
- 3005855240
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3001 Deming Way
- City
- Middleton
- State
- WI
- ZIP
- 53562
- Country
- US
Regulatory Submissions
- 510(k) Number
- K103560
Owner / Operator
- Firm Name
- Spectrum Brands, Inc. (a Delaware Corporation)
- Operator Number
- 10034410
- Address
- 3001 Deming Way
- City
- Middleton
- State
- WI
- Postal Code
- 53562
- Country
- US
- Correspondent
- Tom Baumgard
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | Class 2 | General, Plastic Surgery | No | 2011-12-22 |
Proprietary Names
iLIGHT Pro, Ilight Pro Premier
Establishment Types
Complaint File Establishment per 21 CFR 820.198