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Diode Laser Therapy System
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref FG2000-EModel FG2000-D+; FG2000-D+Pro; FG2000-ERef FG2000-D+ ProRef Diode Laser Therapy SystemModel FG2000-B,FG2000-B Pro,FG2000D+ 001,FG2000D+ 003,FG2000D+005,FG2000D+ 006,QRYO-101104,AlphaSheer Max
Identity
- Trade Name
- Diode Laser Therapy System EUDAMED
- Device Name
- Diode Laser Therapy System EUDAMED
- Model / Reference
- FG2000-D+; FG2000-D+Pro; FG2000-E EUDAMEDFG2000-E EUDAMEDFG2000-D+ Pro EUDAMEDFG2000-B,FG2000-B Pro,FG2000D+ 001,FG2000D+ 003,FG2000D+005,FG2000D+ 006,QRYO-101104,AlphaSheer Max EUDAMEDDiode Laser Therapy System EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970453270838 EUDAMED06970453270821 EUDAMED06970453270791 EUDAMED06970453270777 EUDAMED06970453270753 EUDAMED06970453270760 EUDAMED
- Basic UDI-DI
- 697045327FG20005Q EUDAMED697045327075FG2000D+001X9 EUDAMED
- Direct Marketing DI
- 06970453270838 EUDAMED06970453270791 EUDAMED06970453270777 EUDAMED06970453270753 EUDAMED06970453270760 EUDAMED
- EMDN Code
- Z12011016 DIODE SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Diode Laser Therapy System by Beijing ADSS Development Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231896 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697045327FG20005Q | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing ADSS Development Co., Ltd
- EUDAMED SRN
- CN-MF-000013103
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (7)
- EUDAMED 32507ea9-ce0c-4838-8f11-f2dfbdec0dd8 61 fields · synced Aug 2, 2026
- EUDAMED c9a42129-cf56-49e5-86fc-3b8361c18512 61 fields · synced May 18, 2026
- EUDAMED 9b7b9fc0-2e2b-4e8b-9db6-0fae4536909b 61 fields · synced May 19, 2026
- EUDAMED 27180ef4-09a2-4a8a-aa91-d4d9c2b6465c 61 fields · synced May 19, 2026
- EUDAMED 39ea0fcf-9a14-4fb7-abe5-5a11f956a0ca 61 fields · synced May 19, 2026
- EUDAMED 422a2171-0b54-4de3-bbb3-56e338a1985a 61 fields · synced May 19, 2026
- FDA 510(k) K231896 1 fields · synced May 18, 2026