← Back to catalogue
CO2 Laser Therapy Systems
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 4112Model HS-411
Identity
- Trade Name
- CO2 Laser Therapy Systems EUDAMEDApolomed FDA UDI
- Generic Name
- General/multiple surgical carbon dioxide laser system FDA UDI
- Device Name
- CO2 Laser Therapy Systems EUDAMEDCO2 Laser Therapy System FDA UDI
- Model / Reference
- HS-411 EUDAMEDFDA UDI4112 EUDAMED
- Description
- CO2 Laser Therapy System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970745914112 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970745914112 EUDAMED
- 510(k) Number
- K201109 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011005 CARBON DIOXIDE SURGICAL LASER EUDAMED
- GMDN Term
- General/multiple surgical carbon dioxide 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
- 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
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
CO2 Laser Therapy Systems by Shanghai Apolo Medical Technology Co., Ltd — Class IIb — 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-06970745914112 | 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 5aae1fe2-4c0b-4066-900c-27e1e2e9a1e2 61 fields · synced Jun 19, 2026
- FDA UDI a7842337-f9dd-4434-bd3d-8a2f721f9b29 35 fields · synced May 30, 2026