Identity
- Trade Name
- Star Bio FDA UDI
- Generic Name
- Blue/red/infrared phototherapy lamp FDA UDI
- Device Name
- ScienlodicSciContour Body/Skin, SciVive Hair+BodySciTheraRecover,BioEpicPanel,SB012SB360, led mask FDA UDI
- Model / Reference
- - FDA UDI
- Description
- ScienlodicSciContour Body/Skin, SciVive Hair+BodySciTheraRecover,BioEpicPanel,SB012SB360, led mask FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06977382490047 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Blue/red/infrared phototherapy lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blue/red/infrared phototherapy lamp
Star Bio by Star Bio Co., Ltd — 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
- Star Bio Co., Ltd
Sources (1)
- FDA UDI d89dd7db-fdfc-4bfa-9277-45bbf0961586 33 fields · synced Jun 6, 2026