Identity
- Trade Name
- B.Light Clear Evo EUDAMEDFDA UDIB.Light Restore Evo EUDAMEDFDA UDI
- Generic Name
- Light-energy skin surface treatment system applicator FDA UDI
- Device Name
- Light Applicators EUDAMED
- Model / Reference
- 434500 EUDAMED434600 EUDAMEDBEMER Therapy System Evo FDA UDI
Identifiers
- Catalog Number
- 434500 FDA UDI434600 FDA UDI
- Primary DI / UDI-DI
- 07640161460195 EUDAMEDFDA UDI07640161460201 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016146LIGHTB3 EUDAMED
- Direct Marketing DI
- 07640161460195 EUDAMED07640161460201 EUDAMED
- 510(k) Number
- K223919 FDA UDI
- FDA Product Code
- OHS FDA UDIOLP FDA UDI
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMEDZ12040203 DERMAL REGENERATION EQUIPMENT EUDAMED
- GMDN Term
- Light-energy skin surface treatment system applicator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Red-light phototherapy unit, professional
B.Light Clear Evo by Bemer Int. AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764016146LIGHTB3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- BEMER Int. AG
- EUDAMED SRN
- LI-MF-000002555
Sources (4)
- EUDAMED 4104739f-30ef-4107-9f76-8a4a7491d0f0 61 fields · synced Jul 15, 2026
- EUDAMED 862fac0b-35f2-4bf6-922f-b2f34f25b429 61 fields · synced May 17, 2026
- FDA UDI f4138403-f17f-4501-a62a-a974e53e74d2 34 fields · synced May 30, 2026
- FDA UDI e2873560-29c2-40d0-b4da-778f0b735e29 34 fields · synced May 30, 2026