Data / Medical devices / United States / Coronado Aesthetics LLC
Coronado Aesthetics LLC: FDA-registered device maker in Southlake, TX, United States, 1 510(k) clearance
Coronado Aesthetics LLC is registered with the FDA (registration 3021159346) in Southlake, TX, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 6, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021159346
- Address
- 601 State St Ste 200, Southlake, TX, United States, 76092
- Owner or operator
- Coronado Aesthetics LLC (10083751)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 16, 2021
- Registered through
- 2026
- Brand names listed
- Sebacia Microparticles
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser Absorbing Particles | QCY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 6, 2018 | K181518 | Sebacia Microparticles | QCY | Substantially Equivalent | Sebacia, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 6, 2018. 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.