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Q-Switched Nd:YAG laser systems
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 2552Model HS-255Ref 2507Model HS-250Ref 2903Model HS-290Ref 2200Model HS-220
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-255 EUDAMED2552 EUDAMEDHS-250 EUDAMED2507 EUDAMEDHS-290 EUDAMED2903 EUDAMEDHS-220 EUDAMED2200 EUDAMEDHS-290K FDA UDI
- Description
- EO Q-Switched Nd: YAG Laser Systems FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970745912552 EUDAMED06970745912507 EUDAMED06970745912903 EUDAMEDFDA UDI06970745912200 EUDAMED
- Basic UDI-DI
- B-06970745912552 EUDAMEDB-06970745912507 EUDAMEDB-06970745912903 EUDAMEDB-06970745912200 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 EUDAMEDPoland EUDAMEDFrance EUDAMEDGermany 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 — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K260256 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K190936 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06970745912552 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shanghai Apolo Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000002904
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (6)
- EUDAMED b4187483-a385-49c7-a038-123d8e4795ea 61 fields · synced Jul 24, 2026
- EUDAMED 457581cf-43fd-41b1-a983-3d4f2b92ddb2 61 fields · synced May 17, 2026
- EUDAMED caf62cf1-b299-4df1-a9c7-cf5d9eb21d03 61 fields · synced May 17, 2026
- EUDAMED 4c9944cf-ea9a-4b93-b812-82fbd0e391de 61 fields · synced May 18, 2026
- FDA UDI 0faf362a-b919-4746-b65b-567c776eee4c 36 fields · synced May 30, 2026
- FDA 510(k) K260256 1 fields · synced May 21, 2026