The following data is part of a premarket notification filed by Cartessa Aesthetics with the FDA for Subnovii Advanced Plasma Technology.
| Device ID | K201738 |
| 510k Number | K201738 |
| Device Name: | SubNovii Advanced Plasma Technology |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Cartessa Aesthetics 175 Broadhollow Rd Melville, NY 11747 |
| Contact | Gabe Lubin |
| Correspondent | Connie Hoy Hoy And Associates 3916 North Potsdam Ave Souix Falls, SD 57104 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-25 |
| Decision Date | 2020-09-10 |