Identity
- Trade Name
- HiScan SCAR 3 EUDAMEDScar 3 FDA UDI
- Generic Name
- Skin laser scanner FDA UDI
- Device Name
- Scanning units for CO2 lasers EUDAMEDThe SCAR 3 scanning unit is an optional scanner that can be connected to DEKA CO2 lasers. The SCAR 3 is composed of the following components: - HiScan SCAR 3 head - HiScan SCAR 3 cable Laser emission parameters are selected through the GUI of the DEKA laser device to whom the scanner is connected. Shape and size of the scanning area may also be selected by using the three keys on the scanning head. FDA UDI
- Model / Reference
- F269D1 EUDAMEDFDA UDIE124S1 EUDAMED
- Description
- The SCAR 3 scanning unit is an optional scanner that can be connected to DEKA CO2 lasers. The SCAR 3 is composed of the following components: - HiScan SCAR 3 head - HiScan SCAR 3 cable Laser emission parameters are selected through the GUI of the DEKA laser device to whom the scanner is connected. Shape and size of the scanning area may also be selected by using the three keys on the scanning head. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08034108511399 EUDAMEDFDA UDI08034108511986 EUDAMED
- Basic UDI-DI
- 803410851F49801KD EUDAMED
- 510(k) Number
- K231309 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Skin laser scanner FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Italy 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
HiScan SCAR 3 by Deka M.e.l.a. Srl — 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 | 803410851F49801KD | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Deka M.e.l.a. Srl
- EUDAMED SRN
- IT-MF-000007389
Sources (3)
- EUDAMED 5a018b98-6e73-46c8-aa5d-7aaf32441ac7 61 fields · synced Sep 18, 2026
- EUDAMED ab5836cc-fe64-45a8-bdf4-974e053d60f5 61 fields · synced May 18, 2026
- FDA UDI 7e6c6fc2-ca38-4dc5-bdbd-e7a8b23ac3ad 34 fields · synced May 30, 2026