Opera Evo
510(k) K202041
Opera Evo 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) K202041 on 15 Oct 2020, 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 | NumberK202041 | Date15 Oct 2020 | StatusActive |
Official records
- FDA 510(k) database K202041
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- Withdrawn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 K202041
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 | |||
|---|---|---|---|---|
| Opera Evo PDMS00254 | PDMS00254 | 08059173390700 | — | On the market |
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