Identity
- Trade Name
- Laser Handpiece EUDAMEDDiode Laser System Deep Tissue Handpiece FDA UDI
- Generic Name
- Musculoskeletal/physical therapy laser, professional FDA UDI
- Device Name
- Deep Tissue Handpiece EUDAMEDA reusable topical heating device intended for use with Diode Laser Systems in pain therapy. The device is used with disposable protective shields. FDA UDI
- Model / Reference
- 6400311 EUDAMEDDeep Tissue Handpiece Kit FDA UDI
- Description
- A reusable topical heating device intended for use with Diode Laser Systems in pain therapy. The device is used with disposable protective shields. FDA UDI
Identifiers
- Catalog Number
- 6400311 FDA UDI
- Primary DI / UDI-DI
- 00647529003824 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00647529003824 EUDAMED
- 510(k) Number
- K121286 FDA UDI
- FDA Product Code
- ILY FDA UDI
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Musculoskeletal/physical therapy laser, professional FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5500 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
Yes
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
No
FDA UDI
Laser Handpiece by Biolase Mg Llc — Class I — 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-00647529003824 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 bfbe13e8-6cfa-46e3-a8eb-7bdb3c862ed4 61 fields · synced Jul 9, 2026
- FDA UDI ae29ccaf-e222-4201-b794-3e174d8d2355 36 fields · synced May 29, 2026