The following data is part of a premarket notification filed by Crown Aesthetics with the FDA for Skinpen Precision System.
| Device ID | K202243 |
| 510k Number | K202243 |
| Device Name: | SkinPen Precision System |
| Classification | Powered Microneedle Device |
| Applicant | Crown Aesthetics 5005 Lyndon B. Johnson Frwy., Suite 370 Dallas, TX 75244 |
| Contact | Marie Fogartie |
| Correspondent | Marie Fogartie Crown Aesthetics 5005 Lyndon B. Johnson Frwy., Suite 370 Dallas, TX 75244 |
| Product Code | QAI |
| CFR Regulation Number | 878.4430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-10 |
| Decision Date | 2021-04-02 |