Rohrer Aesthetics Pixel8-RF

PiXel8-RF is a bipolar radiofrequency microneedling system from Rohrer Aesthetics: insulated or non-insulated needles enter the skin and RF energy is delivered through them to coagulate tissue at depth. The current version runs at 4 MHz and was cleared by the FDA under K233147, decided October 25, 2023, as a Special 510(k). Its predicate was Rohrer's own earlier system cleared on July 13, 2018 under K180654 as the PINXEL-RF, which ran at 2 MHz. Rohrer's PiXel8-Reveal filing calls the 2 MHz unit the earlier generation PiXel8. The cleared indication for both is use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

According to the 2023 summary, the system has a main body, a bipolar handpiece that takes disposable microneedle electrode tips, a footswitch and an 8 inch touch screen. Tips come in 25, 49 and 64 pin versions, maximum output is 25 W at 500 ohms, RF duration runs from 50 to 950 ms, and the unit is air cooled on single phase 110 to 230 volt power. Rohrer's product page adds a handpiece with a dial that sets depth from 0.1 mm to 4.0 mm and six tip configurations, and shows the system on a cart.

The quickest way to tell the generations apart is the operating frequency shown on the label or in the software: 2 MHz for the 2018 PINXEL-RF era and 4 MHz for the 2023 PiXel8-RF. The 49 pin tip arrived with the 4 MHz version; the 2018 filing lists only 25 and 64 pin tips. Rohrer's PiX:E and the PiXel8-Reveal add an Er:YAG laser handpiece, so a unit with only the needle handpiece is a PiXel8-RF.

Because the tips are single-use parts, a buyer will ask how many sealed tips of each size are included and whether they remain available. Also document the handpiece cable and depth dial, the footswitch, the cart, the serial label and the startup screen, plus service records.