Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rohrer Aesthetics, LLC — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
239 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233099 | Gladiator | Rohrer Aesthetics, LLC | 2024-05-22 | 239 | 0 |
| K212331 | BodySculp | Rohrer Aesthetics, LLC | 2021-11-09 | 105 | 0 |
| K210535 | UltraLight LED System | Rohrer Aesthetics, LLC | 2021-05-24 | 89 | 0 |
| K192583 | PicoLazer Laser System | Rohrer Aesthetics, LLC | 2020-01-17 | 120 | 0 |
| K191162 | EpiLaze Multi-wavelength Laser | Rohrer Aesthetics, LLC | 2019-07-09 | 69 | 0 |
| K180654 | PINXEL-RF system | Rohrer Aesthetics, LLC | 2018-07-13 | 122 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda