Chrome
510(k) K202503
Chrome is a Class II device made by Quanta System SpA, cleared under FDA 510(k) K202503 on 18 Nov 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 | NumberK202503 | Date18 Nov 2020 | StatusActive |
Official records
- FDA 510(k) database K202503
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- Withdrawn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 K202503
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 | |||
|---|---|---|---|---|
| Chrome PNMS00189 | PNMS00189 | 08059173391806 | — | On the market |
| Chrome PNMS00190 | PNMS00190 | 08059173391813 | — | On the market |
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