The following data is part of a premarket notification filed by Venus Concept Usa Inc. with the FDA for Legacy Bx.
| Device ID | K142910 |
| 510k Number | K142910 |
| Device Name: | Legacy BX |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Venus Concept USA Inc. 4556 N Hiatus Road Sunrise, FL 33351 |
| Contact | Lilia Schlosberg |
| Correspondent | Ahava Stein A. Stein - Regulatory Affairs Consulting Ltd. 175 Derby St., Unit 27 Suite 1 Hingham, MA 02043 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-06 |
| Decision Date | 2014-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016541533 | K142910 | 000 |
| 07290016541472 | K142910 | 000 |
| 07290016540086 | K142910 | 000 |