The following data is part of a premarket notification filed by Novoxel Ltd. with the FDA for Tixel System.
| Device ID | K202988 |
| 510k Number | K202988 |
| Device Name: | Tixel System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Novoxel Ltd. 43 Hamelaha St. Netanya, IL 4250573 |
| Contact | Ronen Shavit |
| Correspondent | Janice M. Hogan Hogan Lovells, US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-30 |
| Decision Date | 2021-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290117524022 | K202988 | 000 |
| 07290117524015 | K202988 | 000 |
| 07290117524008 | K202988 | 000 |
| 07290117524060 | K202988 | 000 |
| 07290117524053 | K202988 | 000 |
| 07290117524046 | K202988 | 000 |