Identity
- Trade Name
- High-Speed (HS) Disposables KIT EUDAMEDFDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Model / Reference
- NA EUDAMEDKT-1063750Be EUDAMEDHigh-Speed (HS) Disposables KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17290117770730 EUDAMEDFDA UDI
- Basic UDI-DI
- 729011777LSTPHT EUDAMED
- 510(k) Number
- K170179 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z129099 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER EUDAMED
- GMDN Term
- Dermatological diode laser system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Belgium 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fixture/appliance dental drill bit, reusable
KT-1063750Be by Lumenis Be Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 729011777LSTPHT | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Lumenis Be LTD
- EUDAMED SRN
- IL-MF-000022063
- Authorised Representative
- Lumenis (Germany) GmbH DE-AR-000007699
Sources (3)
- EUDAMED 1dfffa34-6aed-4726-95c0-6b78a71aaeaf 61 fields · synced Jul 9, 2026
- FDA UDI 1b9331a2-f8a1-475b-b8ef-728be4e4d95d 33 fields · synced May 30, 2026
- EUDAMED a9819bf0-ecfc-4b2a-a7cb-3c70db61dd8e 61 fields · synced Jul 9, 2026