Identity
- Trade Name
- Waterlase Laser Tips - Sapphire EUDAMEDWaterlase Express FDA UDI
- Generic Name
- Dental solid-state laser system FDA UDI
- Device Name
- WL Laser Tips, Starter Kit, 5PK EUDAMEDA kit composed of single-use fiberoptic accessories intended for use with the Waterlase Express all-tissue dental laser system in soft-tissue and hard-tissue procedures. FDA UDI
- Model / Reference
- 7230001 EUDAMEDWaterlase Express Tip Starter Kit, 37pk FDA UDI
- Description
- A kit composed of single-use fiberoptic accessories intended for use with the Waterlase Express all-tissue dental laser system in soft-tissue and hard-tissue procedures. FDA UDI
Identifiers
- Catalog Number
- 7230001 FDA UDI
- Primary DI / UDI-DI
- 00647529003800 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00647529003800 EUDAMED
- 510(k) Number
- K161669 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Dental solid-state laser system FDA UDI
Classification
- Device Class
- Class IIa 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
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Waterlase Laser Tips - Sapphire by Biolase Mg Llc — Class IIa — 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-00647529003800 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Biolase Mg Llc
- EUDAMED SRN
- US-MF-000028587
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED b758eb81-1d50-4ce7-85df-9a030ff9a645 61 fields · synced Jul 14, 2026
- FDA UDI 6c99bf7a-93ea-4106-aadb-b8f4adfd5fd9 36 fields · synced May 26, 2026