Identity
- Trade Name
- DeepFX Air Disposable Tips FDA UDI
- Generic Name
- Laser beam-guide spacer FDA UDI
- Model / Reference
- NA EUDAMEDFDA UDIKT-00055555Be EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17290117771836 EUDAMEDFDA UDI
- Basic UDI-DI
- 729011777DPFXTPSSP EUDAMED
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011080 LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Laser beam-guide spacer FDA UDI
Classification
- Device Class
- Class I 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
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
KT-00055555Be by Lumenis Be Ltd — Class I — 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 | 729011777DPFXTPSSP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 8ce87ff0-4a26-4572-84e5-b71fd8d72a67 61 fields · synced Jun 18, 2026
- FDA UDI d64fc67f-4073-4c00-868c-109fcd676fbf 33 fields · synced May 30, 2026