Identity
- Trade Name
- 2mm cartridge EUDAMEDCLARITY II FDA UDI
- Generic Name
- Dermatological solid-state laser system FDA UDI
- Device Name
- Long-pulsed Alexandrite + Nd:YAG Laser, Long-pulsed Alexandrite Laser EUDAMED
- Model / Reference
- CLARITY II, CLARITY II LPA EUDAMED2mm cartridge FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809447655666 EUDAMEDFDA UDI
- Basic UDI-DI
- 88094476511102AVK EUDAMED
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011012,Z12011019 EUDAMED
- GMDN Term
- Dermatological solid-state laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 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
2mm cartridge by Lutronic Corporation — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88094476511102AVK | Class IIb | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 (3)
- EUDAMED 031425e6-d75d-4468-a933-439de33771b6 61 fields · synced Jul 9, 2026
- FDA UDI 7c9b5e16-2ec8-456f-958e-a03b9f59fd82 32 fields · synced May 29, 2026
- EUDAMED 031425e6-d75d-4468-a933-439de33771b6-1 61 fields · synced Jun 9, 2026