The following data is part of a premarket notification filed by Rohrer Aesthetics, Llc with the FDA for Pinxel-rf System.
| Device ID | K180654 |
| 510k Number | K180654 |
| Device Name: | PINXEL-RF System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Rohrer Aesthetics, LLC 105 Citation Court Homewood, AL 35209 |
| Contact | Mark Rohrer |
| Correspondent | Mark Rohrer Rohrer Aesthetics, LLC 105 Citation Court Homewood, AL 35209 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-13 |
| Decision Date | 2018-07-13 |
| Summary: | summary |