Identity
- Trade Name
- HEAD-830nm/590nm EUDAMEDN/A FDA UDI
- Generic Name
- Red-light phototherapy unit, professional FDA UDI
- Device Name
- Phototherapy Unit EUDAMEDHealite II 830&590nm Head (830/590nm head) FDA UDI
- Model / Reference
- HEALITE II EUDAMED830&590nm Head FDA UDI
- Description
- Healite II 830&590nm Head (830/590nm head) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809447651675 EUDAMEDFDA UDI
- Basic UDI-DI
- 88094476510704AWQ EUDAMED
- 510(k) Number
- K113668 FDA UDI
- FDA Product Code
- ILY FDA UDI
- EMDN Code
- Z12040299 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Red-light phototherapy unit, professional FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5500 FDA UDI
- Market of Registration
- Netherlands 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dermatological laser beam guiding handpiece
HEAD-830nm/590nm by Lutronic Corporation — 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 | 88094476510704AWQ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Lutronic Corporation
- EUDAMED SRN
- KR-MF-000009035
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 0d438eb2-8edf-43b6-af5e-1eb0533411fe 61 fields · synced Jul 20, 2026
- FDA UDI a2e213d5-bab0-4c00-9f13-d0827835d873 36 fields · synced May 30, 2026