Identity
- Trade Name
- OrthoPulse FDA UDI
- Generic Name
- Red-light phototherapy unit, professional FDA UDI
- Model / Reference
- OPi FDA UDI
Identifiers
- Catalog Number
- OPi-NA100 FDA UDI
- Primary DI / UDI-DI
- 09120118090029 FDA UDI
- 510(k) Number
- K143120 FDA UDI
- FDA Product Code
- PLH FDA UDI
- GMDN Term
- Red-light phototherapy unit, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 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
No
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
Yes
FDA UDI
Category: Red-light phototherapy unit, professional
OrthoPulse by Biolux Technology GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K143120 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 |
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Manufacturer
- Manufacturer
- Biolux Technology GmbH
Sources (1)
- FDA UDI 71ec7994-6514-489f-8167-319b08f92d74 35 fields · synced Jun 1, 2026