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 |