Data / Medical devices / United States / Rohrer Aesthetics, Inc.
Rohrer Aesthetics, Inc.: FDA-registered device maker in Homewood, AL, United States, 15 510(k) clearances
Rohrer Aesthetics, Inc. is registered with the FDA (registration 3031944951) in Homewood, AL, United States. It lists 9 device types. The FDA files 15 510(k) clearances under its listings, the newest dated September 26, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031944951
- Address
- 121 Citation Ct, Homewood, AL, United States, 35209
- Owner or operator
- Rohrer Aesthetics, Inc. (10091003)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 13, 2024
- Registered through
- 2026
- Brand names listed
- Apollo, BodySculp, BodyTone, EpiLaze, Gladiator, InPulsa, Light Bed, Phoenix and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 26, 2025 | K251919 | Thulium Laser System (Deluxlase) | GEX | Substantially Equivalent | Nanjing Bestview Laser S&T Co., Ltd. | accessdata.fda.gov |
| May 22, 2024 | K233099 | Gladiator | GEI | Substantially Equivalent | Rohrer Aesthetics, LLC | accessdata.fda.gov |
| March 15, 2024 | K233307 | Intensity Pulsed Light Therapy System | ONF | Substantially Equivalent | Beijing Adss Development Co., Ltd. | accessdata.fda.gov |
| February 2, 2024 | K233143 | PiXel8-Reveal | GEX | Substantially Equivalent | Rohrer Aesthetics | accessdata.fda.gov |
| October 25, 2023 | K233147 | PiXel8-RF | GEI | Substantially Equivalent | Rohrer Aesthetics | accessdata.fda.gov |
| May 24, 2021 | K210535 | UltraLight LED System | GEX | Substantially Equivalent | Rohrer Aesthetics, LLC | accessdata.fda.gov |
| January 17, 2020 | K192583 | PicoLazer Laser System | GEX | Substantially Equivalent | Rohrer Aesthetics, LLC | accessdata.fda.gov |
| July 17, 2019 | K191068 | Powersculp laser lipolysis system | PKT | Substantially Equivalent | Wuhan Lotuxs Technology Co., Ltd. | accessdata.fda.gov |
| July 9, 2019 | K191162 | EpiLaze Multi-wavelength Laser | GEX | Substantially Equivalent | Rohrer Aesthetics, LLC | accessdata.fda.gov |
| July 13, 2018 | K180654 | PINXEL-RF system | GEI | Substantially Equivalent | Rohrer Aesthetics, LLC | accessdata.fda.gov |
| April 11, 2013 | K123777 | MULTILASER SYSTEM | GEX | Substantially Equivalent | Ultralight Laser Technologies, LLC | accessdata.fda.gov |
| December 14, 2012 | K113018 | APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM | GEX | Substantially Equivalent | BEIJING SYNTECH LASER CO., LTD. | accessdata.fda.gov |
| November 3, 2011 | K102524 | FUTURA | IMG | Substantially Equivalent | Dr. Oliver Wenker, M.D., M.B.A. | accessdata.fda.gov |
| April 19, 2011 | K110434 | TRIXEL CO2 LASER | GEX | Substantially Equivalent | BEIJING SYNTECH LASER CO., LTD. | accessdata.fda.gov |
| November 2, 2004 | K042496 | ADEPT ULTRALITE 532 LASER | GEX | Substantially Equivalent | Adept Medical Concepts | accessdata.fda.gov |
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Updated September 26, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.