Identity
- Trade Name
- System Main Body EUDAMEDHealite II FDA UDI
- Generic Name
- Red-light phototherapy unit, professional FDA UDI
- Device Name
- Phototherapy Unit EUDAMEDHealite Body Assy (System Main Body) FDA UDI
- Model / Reference
- HEALITE II EUDAMEDHealite Body Assy FDA UDI
- Description
- Healite Body Assy (System Main Body) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809447651699 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Dermatological laser beam guiding handpiece
System Main Body by Lutronic Corporation — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113668 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88094476510704AWQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lutronic Corporation
- EUDAMED SRN
- KR-MF-000009035
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 513203a8-7c44-4fcc-877b-4c676220a596 61 fields · synced Jul 14, 2026
- FDA UDI 9d09dc36-44c6-43a9-89b9-ac5b4571166c 36 fields · synced May 30, 2026
- FDA 510(k) K113668 1 fields · synced May 18, 2026