Data / Medical devices / United States / Optometric Aesthetics, LLC
Optometric Aesthetics, LLC: FDA-registered device maker in Riverton, UT, United States, 5 510(k) clearances
Optometric Aesthetics, LLC is registered with the FDA (registration 3025268687) in Riverton, UT, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 1, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025268687
- Address
- 2778 W 12600 S Ste.103, Riverton, UT, United States, 84065
- Owner or operator
- Optometric Aesthetics, LLC (10086655)
- Roles
- Repackager or relabeler
- First device listed
- December 2, 2022
- Registered through
- 2026
- Brand names listed
- iLight IPL, iLight IPL Pro, iLight LED Pro, iLight LLLT Pro, iLight LLLT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Repackager or relabeler | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| February 1, 2023 | K222751 | LED Light Therapy Device, KN-7000L | GEX | Substantially Equivalent | Xuzhou Kernel Medical Equipment Co., Ltd. | accessdata.fda.gov |
| August 12, 2022 | K220385 | Intense Pulsed Light Equipment | ONF | Substantially Equivalent | Beijing Globalipl Development Co., Ltd. | accessdata.fda.gov |
| April 3, 2020 | K192735 | Diode Laser Hair Removal Machine | GEX | Substantially Equivalent | Beijing Lead Beauty S & T Co., Ltd. | accessdata.fda.gov |
| March 25, 2020 | K193328 | IPL + Diode Laser Machine | ONF | Substantially Equivalent | Beijing Globalipl Development Co., Ltd. | accessdata.fda.gov |
| July 28, 2017 | K170187 | Photodynamic Therapy Device | GEX | Substantially Equivalent | Uvbiotek, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Updated February 1, 2023. 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.