Identity
- Trade Name
- UltraClear EUDAMEDFDA UDI
- Generic Name
- Dermatological solid-state laser system FDA UDI
- Device Name
- UltraClear Fractional Laser System EUDAMEDFractional Mid IR Fiber Laser System (White) FDA UDI
- Model / Reference
- AS-WT-00055 EUDAMEDFDA UDI
- Description
- Fractional Mid IR Fiber Laser System (White) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850039149016 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850039149AS-WT-00055QN EUDAMED
- Direct Marketing DI
- 00850039149016 EUDAMED
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011006 DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER 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
- Germany 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
UltraClear by Acclaro Corporation — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0850039149AS-WT-00055QN | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Acclaro Corporation
- EUDAMED SRN
- US-MF-000039603
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 4a684b22-973b-4a4f-9116-4e8272c4ce92 61 fields · synced Jun 9, 2026
- FDA UDI 2f22644a-d8ce-47bc-ad04-eebf4e069ad0 35 fields · synced May 29, 2026