Identity
- Trade Name
- iLase Laser System EUDAMEDiLase Diode Laser System FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- iLase EUDAMEDiLase Diode Laser System is designed for a variety of dental soft tissue procedures. The iLase system consists of one iLase handpiece and the iLase charging station used for charging and storing the handpiece and replacement batteries. Other systems components include protective eyewear, rechargeable batteries, charging station power supply, handpiece cover grips, laser tips and a tip cleaning kit. The handpiece is a reusable device with a removable cover which requires sterilization prior to each patient use. FDA UDI
- Model / Reference
- 7400040-01 EUDAMEDiLase FDA UDI
- Description
- iLase Diode Laser System is designed for a variety of dental soft tissue procedures. The iLase system consists of one iLase handpiece and the iLase charging station used for charging and storing the handpiece and replacement batteries. Other systems components include protective eyewear, rechargeable batteries, charging station power supply, handpiece cover grips, laser tips and a tip cleaning kit. The handpiece is a reusable device with a removable cover which requires sterilization prior to each patient use. FDA UDI
Identifiers
- Catalog Number
- 7400040-01 FDA UDI
- Primary DI / UDI-DI
- 00647529002322 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00647529002322 EUDAMED
- 510(k) Number
- K093852 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011014 ERBIUM 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
- 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
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
iLase Laser System by Biolase Mg Llc — 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-00647529002322 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 9ec52761-e44d-4bbd-9a8a-985cd4eadd28 61 fields · synced Jun 19, 2026
- FDA UDI 68e91b11-15a4-40ed-81d5-6fb79c37efbb 36 fields · synced May 29, 2026