← Back to catalogue
Q-Switched Nd:YAG laser systems
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 2910Model HS-290E
Identity
- Trade Name
- Q-Switched Nd:YAG laser systems EUDAMEDApolomed FDA UDI
- Generic Name
- Dermatological frequency-doubled solid-state laser system FDA UDI
- Device Name
- Dermatological Frequency-doubled (Nd: YAG) Solid-state Laser Systems EUDAMEDEO Q-Switched Nd:YAG Laser Systems FDA UDI
- Model / Reference
- HS-290E EUDAMED2910 EUDAMEDHS-290EK FDA UDI
- Description
- EO Q-Switched Nd:YAG Laser Systems FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970745912910 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970745912910 EUDAMED
- 510(k) Number
- K190936 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011006 DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER EUDAMED
- GMDN Term
- Dermatological frequency-doubled solid-state laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- Not 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Q-Switched Nd:YAG laser systems by Shanghai Apolo Medical Technology Co., Ltd — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-06970745912910 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai Apolo Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000002904
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 1d3d86f1-f3e5-4bdf-a978-c2aa22127cb7 61 fields · synced Jun 20, 2026
- FDA UDI 5b55fac3-6485-4e38-b9f8-482cbda554ab 36 fields · synced May 30, 2026