EVO platform
by Quanta System SpA 3 variants
510(k) K160368
EVO platform 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) K160368 on 5 Apr 2016, 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 | NumberK160368 | Date5 Apr 2016 | StatusActive |
Official records
- FDA 510(k) database K160368
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- Withdrawn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 K160368
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 | |||
|---|---|---|---|---|
| Twain Evo OAM002010 | OAM002010 | 08059173390069 | — | On the market |
| Twain Evo OAM002011 | OAM002011 | 08059173390076 | — | On the market |
| Twain Evo OAM002012 | OAM002012 | 08059173390083 | — | On the market |
| Twain Evo OAM002013 | OAM002013 | 08059173390090 | — | On the market |
| Twain Evo OAM002014 | OAM002014 | 08059173390106 | — | On the market |
| Twain Evo OAM002015 | OAM002015 | 08059173390113 | — | On the market |
| Twain Evo OAM002016 | OAM002016 | 08059173390120 | — | On the market |
| Twain Evo OAM002017 | OAM002017 | 08059173390137 | — | On the market |
| Twain Evo OAM002018 | OAM002018 | 08059173390144 | — | On the market |
| Twain Evo OAM002019 | OAM002019 | 08059173390151 | — | On the market |
| Twain Evo OAM002020 | OAM002020 | 08059173390168 | — | On the market |
| Twain Evo OAM002021 | OAM002021 | 08059173390175 | — | On the market |
| Twain Evo OAM002023 | OAM002023 | 08059173390182 | — | On the market |
| Twain Evo OAM002024 | OAM002024 | 08059173390199 | — | On the market |
| Twain Evo OAM002025 | OAM002025 | 08059173390205 | — | On the market |
| Twain Evo OAM002026 | OAM002026 | 08059173390212 | — | On the market |
| Twain Evo OAM002027 | OAM002027 | 08059173390229 | — | On the market |
| Twain Evo OAM002028 | OAM002028 | 08059173390236 | — | On the market |
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