Echo
510(k) K232236
Echo is a medical device (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, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232236 | Date20 Oct 2023 | StatusActive |
Official records
- FDA 510(k) database K232236
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K232236
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Echo | PDMS00257 / Echo | 08059173396375 | — | On the market |
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Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).
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- XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 by Photo Medex, Inc.
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