Identity
- Trade Name
- ResurFX™ SapphireCool™ Tip FDA UDI
- Generic Name
- Dermatological laser beam guiding handpiece FDA UDI
- Model / Reference
- NA EUDAMEDFDA UDIKT-10000965Be EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290117770436 EUDAMEDFDA UDI
- Basic UDI-DI
- 729011777RFXTPJM EUDAMED
- 510(k) Number
- K193500 FDA UDI
- FDA Product Code
- ONG FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Dermatological laser beam guiding handpiece 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Device sterilization/disinfection container, reusable
KT-10000965Be by Lumenis Be Ltd — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Device sterilization/disinfection container, reusable.
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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 | 729011777RFXTPJM | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 (2)
- EUDAMED 94ebcf33-5042-46b9-b5db-a16837345085 61 fields · synced Jun 17, 2026
- FDA UDI 3e8f0af4-3ad9-4972-acac-71c4790d20dd 33 fields · synced May 30, 2026