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Picosecond Nd:YAG Laser Systems
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 2996Model HS-298510(k) K200116
Identity
- Trade Name
- Picosecond Nd:YAG Laser Systems EUDAMED
- Device Name
- Picosecond Nd:YAG Laser Systems EUDAMED
- Model / Reference
- HS-298 EUDAMED2996 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970745912996 EUDAMED
- Basic UDI-DI
- B-06970745912996 EUDAMED
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Picosecond Nd:YAG Laser Systems by Shanghai Apolo Medical Technology Co., Ltd — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K200116 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06970745912996 | 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 (2)
- EUDAMED d355f597-27c8-41b0-941b-27456861c37d 85 fields · synced Jun 18, 2026
- FDA 510(k) K200116 1 fields · synced May 18, 2026