Identity
- Trade Name
- Thunder VT EUDAMEDFDA UDI
- Generic Name
- Dermatological solid-state laser system FDA UDI
- Device Name
- Thunder VT EUDAMED
- Model / Reference
- Thunder VT EUDAMEDPCMS00402 EUDAMEDPCMS00406 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08059173391578 EUDAMED08033945936976 FDA UDI
- Basic UDI-DI
- B-08059173391578 EUDAMED
- 510(k) Number
- K171711 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011019 MULTI–PLATFORM LASER EUDAMED
- GMDN Term
- Dermatological solid-state laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Italy 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
Category: Dermatological solid-state laser system
Thunder VT by Quanta System Spa — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological solid-state laser system.
- CLARITY II — Lutronic Corporation · Class II
- AuraLux — Acclaro Corporation · Class II
- GentleMax Pro — Candela Corporation · Class II
- CLARITY II — Lutronic Corporation · Class II
- GentleYAG — Candela Corporation · Class II
- Splendor X — Bios, Inc. · Class II
- EPY-50 — DDC TECHNOLOGIES, INC. · Class II
- Canister HFC-134a /980g, ALUM, 15 pack — Candela Corporation · Class II
Cleared under the same submission
K171711 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Quanta System Spa
Sources (2)
- FDA UDI c94b3a09-566a-4d0f-bb85-2c109f90b910 33 fields · synced Jul 11, 2026
- EUDAMED 505e4e36-98ae-40bb-8403-49ab49bc845a 61 fields · synced Jul 11, 2026