Identity
- Trade Name
- NuFACE FDA UDI
- Generic Name
- Cosmetic red-light phototherapy system, home-use FDA UDI
- Device Name
- Trinity+ PRO w/TWR+ & ELE+ Kit FDA UDI
- Model / Reference
- 42019 FDA UDI
- Description
- Trinity+ PRO w/TWR+ & ELE+ Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810075941449 FDA UDI
- FDA Product Code
- OHS FDA UDINFO FDA UDI
- GMDN Term
- Cosmetic red-light phototherapy system, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI882.5890 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
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation systemCosmetic red-light phototherapy system, home-use
NuFACE by Nuface — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K201782 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nuface
Sources (1)
- FDA UDI 922ddf70-c2f5-4a2a-858a-746a66048c9f 34 fields · synced May 30, 2026