← Back to catalogue
CO2 Laser Therapy Systems
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 4129Model HS-411A
Identity
- Trade Name
- CO2 Laser Therapy Systems EUDAMEDApolomed FDA UDI
- Generic Name
- General/multiple surgical carbon dioxide laser system FDA UDI
- Device Name
- Multiple Surgical CO2 Laser Systems EUDAMEDCO2 Laser Therapy System FDA UDI
- Model / Reference
- HS-411A EUDAMEDFDA UDI4129 EUDAMED
- Description
- CO2 Laser Therapy System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970745914129 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970745914129 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
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
CO2 Laser Therapy 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201109 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06970745914129 | Class IIb | Active |
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 (3)
- EUDAMED 83591743-24a1-4909-8063-8931d2653642 61 fields · synced Jul 8, 2026
- FDA UDI 935d58fd-08c8-4126-b555-5ef9fee1d379 35 fields · synced May 25, 2026
- FDA 510(k) K201109 1 fields · synced May 18, 2026