Identity
- Trade Name
- Me FDA UDI
- Generic Name
- Red/blue light phototherapy unit FDA UDI
- Device Name
- Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for the treatment of wrinkles, rhytides and fine lines in the periorbital region. This is a store display. FDA UDI
- Model / Reference
- Series 15 FDA UDI
- Description
- Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for the treatment of wrinkles, rhytides and fine lines in the periorbital region. This is a store display. FDA UDI
Identifiers
- Catalog Number
- HU-CO00901 FDA UDI
- Primary DI / UDI-DI
- 00806248007463 FDA UDI
- FDA Product Code
- OHS FDA UDI
- GMDN Term
- Red/blue light phototherapy unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Red/blue light phototherapy unit
Me by Tanda Beauty Canada, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tanda Beauty Canada, Inc
Sources (1)
- FDA UDI 9807044f-d262-4159-a365-fdf7a8b950e3 34 fields · synced Jun 1, 2026