Identity
- Trade Name
- TheraClear FDA UDI
- Generic Name
- Multi-modality skin surface treatment system generator FDA UDI
- Model / Reference
- 40-TC116-00.AA FDA UDI
Identifiers
- Catalog Number
- 40-TC116 FDA UDI
- Primary DI / UDI-DI
- B305THERACLEAR10 FDA UDI
- 510(k) Number
- K123889 FDA UDI
- FDA Product Code
- ONF FDA UDI
- GMDN Term
- Multi-modality skin surface treatment system generator 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multi-modality skin surface treatment system generator
TheraClear by Theravant Corporation — 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
- Theravant Corporation
Sources (1)
- FDA UDI c98e917d-5a70-4a8d-8680-0bf06a573dd7 35 fields · synced Jun 8, 2026