Tixel System
by Novoxel Ltd
510(k) K202988
Tixel System is a medical device (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Novoxel Ltd, cleared under FDA 510(k) K202988 on 25 Feb 2021, 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 | NumberK202988 | Date25 Feb 2021 | StatusActive |
Official records
- FDA 510(k) database K202988
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEI
- FDA applicant
- Novoxel , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K202988
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 | |||
|---|---|---|---|---|
| Tixel C MSTX0002 | MSTX0002 | 07290117524046 | — | On the market |
| Tixel Handpiece MSH00001 | MSH00001 | 07290117524053 | — | On the market |
| Tixel Handpiece THLM0002 | THLM0002 / THLM0002 | 07290117524015 | — | On the market |
| Tixel Periorbital Handpiece TPH00001 | TPH00001 / TPH00001 | 07290117524022 | — | On the market |
| Tixel TXLD0002 | TXLD0002 / TXLD0002 | 07290117524008 | — | On the market |
| Tixel-Small Tip Handpiece MPH00001 | MPH00001 | 07290117524060 | — | On the market |
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