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O type tip (small size)
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref CLARITY II, CLARITY II LPA
Identity
- Trade Name
- O type tip (small size) 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 EUDAMEDO Type IntelliTrak tip FDA UDI
- Model / Reference
- CLARITY II, CLARITY II LPA EUDAMEDO type tip (small size) FDA UDI
- Description
- O Type IntelliTrak tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809447655857 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
Yes
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
O type tip (small size) 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 9d559d8a-ab38-485a-a11b-a5a3ea08d508 61 fields · synced Jul 9, 2026
- FDA UDI d028969a-121e-4390-ac2a-c404345e43e9 34 fields · synced May 30, 2026
- EUDAMED 9d559d8a-ab38-485a-a11b-a5a3ea08d508-1 61 fields · synced Jun 9, 2026