F50 Normal Tip_D
by Cynosure Lutronic Technology Corporation
Ref F50 Normal Tip_DModel Static Tip 120, Static Tip 300, Static Tip 500, Static Tip Set, F100 handpiece, F100 connector, F100 connector_D, F100 normal tip, F50 handpiece, F50 Normal tip, F50 Normal Tip_D, Zoom handpiece, Zoom connector, Zoom connector_D, F50 handpiece,F100 handpiece,Zoom handpiece,F100 connector,F100 connector_D,Zoom connector,Zoom connector_D,F50 Tip head 90,F50 Tip head 120,F100 Tip head 90,F100 Tip head 120,F100 Tip head 180,Defocus Tip head,F50 Normal Tip,F50 Normal Tip_D
Active
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number88002918210409aKP | Date2 Jul 2026 | StatusActive |
| United States | GUDID listing GUDID | Number08800291821290 | Date15 Apr 2026 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- F50 Normal Tip_D EUDAMEDeCO2 3D GUDID
- Generic Name
- Dermatological carbon dioxide laser system
- Device Name
- eCO2 3D AccessorieseCO2 DENTA Accessories
- Model / Reference
- Static Tip 120, Static Tip 300, Static Tip 500, Static Tip Set, F100 handpiece, F100 connector, F100 connector_D, F100 normal tip, F50 handpiece, F50 Normal tip, F50 Normal Tip_D, Zoom handpiece, Zoom connector, Zoom connector_D, F50 Tip head 90, F50 Tip head 120, F100 Tip head 90, F100 Tip head 120, F100 Tip head 180, Defocus Tip head
- Primary DI / UDI-DI
- 08800291821290, 08800291822068
- Basic UDI-DI
- 88002918210409aKP, 88002918210409bKR
- FDA Product Code
- ONG
- EMDN Code
- Z12011080 Laser surgery instruments - hardware accessories
- GMDN Term
- Dermatological carbon dioxide laser system
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 878.4810
- Market of Registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- KR-MF-000047499
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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See all devices from Cynosure Lutronic Technology Corporation →
Properties
Other properties (22)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No