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Dental diode laser
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref PK2M-02Model K2 Mobile
by Hulaser
Identity
- Trade Name
- K2 MOBILE FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- Dental diode laser EUDAMEDK2 MOBILE LASER IS INTENDED FOR USE BY DENTISTS FOR EXCISION, INCISION, VAPORIZATION, ABLATION AND COAGULATION OF ORAL SOFT TISSUE PROCEDURES, INCLUDING TOOTH WHITENING AND THE TEMPORARY RELIEF OF PAIN. FDA UDI
- Model / Reference
- K2 Mobile EUDAMEDFDA UDIPK2M-02 EUDAMED
- Description
- K2 MOBILE LASER IS INTENDED FOR USE BY DENTISTS FOR EXCISION, INCISION, VAPORIZATION, ABLATION AND COAGULATION OF ORAL SOFT TISSUE PROCEDURES, INCLUDING TOOTH WHITENING AND THE TEMPORARY RELIEF OF PAIN. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800079000008 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800079000008 EUDAMED
- 510(k) Number
- K200693 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011016 DIODE SURGICAL LASER EUDAMED
- GMDN Term
- Dental diode laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Dental diode laser by Hulaser — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800079000008 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Hulaser
- EUDAMED SRN
- KR-MF-000008621
- Authorised Representative
- OMC NI MEDICAL LIMITED XI-AR-000019483
Sources (2)
- EUDAMED 543625fd-ca86-4714-9bb5-a6d473082b4f 61 fields · synced Aug 2, 2026
- FDA UDI 8f46421c-9916-4fad-afa4-d8482dd171b9 35 fields · synced May 30, 2026