Identity
- Trade Name
- ProWave LX EUDAMEDFDA UDI
- Generic Name
- Light-energy skin surface treatment system applicator FDA UDI
- Device Name
- ProWave LX EUDAMEDProWave LX IPL Handpiece FDA UDI
- Model / Reference
- 7001049 EUDAMEDProWave LX FDA UDI
- Description
- ProWave LX IPL Handpiece FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816722022134 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816722022134 EUDAMED
- 510(k) Number
- K050047 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011019 MULTI–PLATFORM LASER EUDAMED
- GMDN Term
- Light-energy skin surface treatment system applicator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- France 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ProWave LX by Cutera, Inc. — 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-00816722022134 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Cutera, Inc.
- EUDAMED SRN
- US-MF-000010456
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED c8eab57b-3b60-4d07-bfaf-dda7a6bc202e 61 fields · synced Jun 18, 2026
- FDA UDI 1e4f92fd-65dd-4713-a4e1-47a5cf1eefe2 35 fields · synced May 29, 2026