Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Rohrer Aesthetics, LLC with 8 510(k) clearances. The most recent is a 510(k) clearance dated May 22, 2024: Gladiator.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 22, 2024 | GladiatorK233099 · GEI | 510(k) clearances |
| Feb 2, 2024 | PiXel8-RevealK233143 · GEX | 510(k) clearances |
| Oct 25, 2023 | PiXel8-RFK233147 · GEI | 510(k) clearances |
| Nov 9, 2021 | BodySculpK212331 · PKT | 510(k) clearances |
| May 24, 2021 | UltraLight LED SystemK210535 · GEX | 510(k) clearances |
| Jan 17, 2020 | PicoLazer Laser SystemK192583 · GEX | 510(k) clearances |
| Jul 9, 2019 | EpiLaze Multi-wavelength LaserK191162 · GEX | 510(k) clearances |
| Jul 13, 2018 | PINXEL-RF systemK180654 · GEI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
