Echo
Echo (PDMS00257) is a dermatological diode laser system (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Quanta System SpA, cleared under FDA 510(k) K232236 on 20 Oct 2023 and listed in FDA GUDID since 21 Jun 2024 (UDI-DI 08059173396375), active as of 8 Jun 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08059173396375 | Date21 Jun 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK232236 | Date20 Oct 2023 | StatusActive |
Official records
- AccessGUDID record 08059173396375
- FDA 510(k) database K232236
Across registries
- FDA 510(k) K232236 decided 20 Oct 2023 Active
- FDA GUDID UDI-DI 08059173396375 listed 21 Jun 2024 Listed
Timeline
- Cleared FDA 510(k) K232236
- Listed FDA GUDID 08059173396375
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Dermatological diode laser system
- Model / Ref / Catalog
- Echo, PDMS00257
- Primary DI / UDI-DI
- 08059173396375
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Dermatological diode laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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