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Celluma
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 850523007310Model CellumaRef 850523007013Model Celluma PODRef 850523007082Model Celluma SPORT - EURef 850523007020Model Celluma SKIN - EU510(k) K211038Ref 850523007167Model Celluma DELUX - EURef 850523007068Model Celluma FACE - EU
Identity
- Trade Name
- Celluma EUDAMED
- Device Name
- Celluma ELITE EUDAMED
- Model / Reference
- Celluma EUDAMED850523007310 EUDAMEDCelluma POD EUDAMED850523007013 EUDAMEDCelluma SPORT - EU EUDAMED850523007082 EUDAMEDCelluma SKIN - EU EUDAMED850523007020 EUDAMEDCelluma DELUX - EU EUDAMED850523007167 EUDAMEDCelluma FACE - EU EUDAMED850523007068 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850523007310 EUDAMED00850523007013 EUDAMED00850523007082 EUDAMED00850523007020 EUDAMED00850523007167 EUDAMED00850523007068 EUDAMED
- Basic UDI-DI
- B-00850523007310 EUDAMEDB-00850523007013 EUDAMEDB-00850523007082 EUDAMEDB-00850523007020 EUDAMEDB-00850523007167 EUDAMEDB-00850523007068 EUDAMED
- 510(k) Number
- K211038 FDA 510(k)
- FDA Product Code
- OAP FDA 510(k)
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5500 FDA 510(k)
- Regulation Number
- 890.5500 FDA 510(k)
- Market of Registration
- France EUDAMED
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Red-light phototherapy unit, professional
Celluma by BioPhotas, Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211038 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00850523007310 | Class IIa | Active |
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Manufacturer
- Manufacturer
- BioPhotas, Inc.
- EUDAMED SRN
- US-MF-000013481
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (7)
- EUDAMED 976efb33-0b82-47b6-b205-bccc7249af4a 61 fields · synced Aug 4, 2026
- EUDAMED 19eace6d-65d2-40dc-b852-ce115f124a88 61 fields · synced May 11, 2026
- EUDAMED 9e2e3a33-8181-448b-a19d-b64eb009a59c 61 fields · synced May 16, 2026
- EUDAMED 4f1bd587-4b8f-4b7d-9e02-581bc46c8fc0 61 fields · synced May 17, 2026
- FDA 510(k) K211038 24 fields · synced May 18, 2026
- EUDAMED a54f92aa-35a7-456b-9c9d-210097c8de0b 61 fields · synced Aug 3, 2026
- EUDAMED 28605836-f604-4214-b687-bff653ebd50e 61 fields · synced Aug 4, 2026