FDA Registration
Inactive
🇨🇦 Canada
Silk'n LED Neck Mask
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SILKN CANADA CORP.
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4550 HIGHWAY 7 UNIT 206
- City
- WOODBRIDGE Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K223544
Owner / Operator
- Firm Name
- SILKN CANADA CORP.
- Operator Number
- 10093700
- Address
- 4550 HIGHWAY 7 UNIT 206
- City
- WOODBRIDGE
- State
- Ontario
- Postal Code
- L4L4Y7
- Country
- CA
- Correspondent
- SANDRA COCKBURN
US Agent
- Business Name
- N/A
- Contact Name
- N/A
- Address
- N/A, N/A
- City
- N/A
- State
- NA
- ZIP
- N/A
- Country
- US
- N/A
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2025-06-25 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2025-06-25 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2025-06-25 |
Proprietary Names
Silk'n LED Neck Mask
LED light therapy mask
Silk'n Led Face Mask 100
Establishment Types
Export Device to the United States But Perform No Other Operation on Device