Rohrer Aesthetics, LLC: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Rohrer Aesthetics, LLC” (first 2018, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 112 days. Since 2017 the median was 112 days, against 98 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 122 |
| 2019 | 1 | 69 |
| 2020 | 1 | 120 |
| 2021 | 2 | 97 |
| 2022 | 0 | — |
| 2023 | 1 | 28 |
| 2024 | 2 | 184 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Rohrer Aesthetics, LLC took a median 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| PKT | Laser For Disruption Of Adipocyte Cells For Aesthetic Use | 1 | 1 |
Review panels
Most recent Rohrer Aesthetics, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233099 | Gladiator | GEI | 2024-05-22 | 239 |
| K233143 | PiXel8-Reveal | GEX | 2024-02-02 | 128 |
| K233147 | PiXel8-RF | GEI | 2023-10-25 | 28 |
| K212331 | BodySculp | PKT | 2021-11-09 | 105 |
| K210535 | UltraLight LED System | GEX | 2021-05-24 | 89 |
| K192583 | PicoLazer Laser System | GEX | 2020-01-17 | 120 |
| K191162 | EpiLaze Multi-wavelength Laser | GEX | 2019-07-09 | 69 |
| K180654 | PINXEL-RF system | GEI | 2018-07-13 | 122 |
Recalls
openFDA lists no recalls under a recalling firm named Rohrer Aesthetics, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Rohrer Aesthetics, LLC?
FDA lists 8 510(k) clearances under the applicant name “Rohrer Aesthetics, LLC” (first 2018, latest 2024), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Rohrer Aesthetics, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rohrer Aesthetics, LLC is 112 days. Since 2017: 112 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Rohrer Aesthetics, LLC?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 4); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); PKT (Laser For Disruption Of Adipocyte Cells For Aesthetic Use, 1).
Next steps
- See all 8 Rohrer Aesthetics, LLC clearances with predicates and recalls
- Run predicate analysis for product code GEX, Rohrer Aesthetics, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.