Data / Medical devices / United States / Curallux, LLC
Curallux, LLC: FDA-registered device maker in Miami, FL, United States, 7 510(k) clearances
Curallux, LLC is registered with the FDA (registration 3010123655) in Miami, FL, United States. It lists 2 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 12, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010123655
- Address
- 1715 NW 82nd Ave, Miami, FL, United States, 33126
- Owner or operator
- Curallux LLC (10048618)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- February 3, 2015
- Registered through
- 2027
- Brand names listed
- Capillis Pro S2, Capillus, Capillus Focal Crown, Capillus Focal Medial, Capillus Focal Temples, Capillus MD, Capillus MD Duo, Capillus OfficePro and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Laser, Comb, Hair | OAP | 2 | Complaint file establishment, Manufacturer | 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 12, 2019 | K192012 | Capillus 112, Capillus 244 | OAP | Substantially Equivalent | Capillus | accessdata.fda.gov |
| January 31, 2017 | K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 | OAP | Substantially Equivalent | Capillus, LLC | accessdata.fda.gov |
| November 18, 2016 | K162994 | Capillus302, Capillus312, Capillus352 | OAP | Substantially Equivalent | Capillus, LLC | accessdata.fda.gov |
| January 19, 2016 | K153618 | Capillus202 | OAP | Substantially Equivalent | Capillus, LLC | accessdata.fda.gov |
| August 21, 2015 | K151516 | Capillus82 | OAP | Substantially Equivalent | Capillus, LLC | accessdata.fda.gov |
| June 9, 2015 | K150578 | Capillus 272 Office Pro | OAP | Substantially Equivalent | Capillus, LLC | accessdata.fda.gov |
| January 29, 2015 | K143199 | Capillus 272 Pro | OAP | Substantially Equivalent | Capillus, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 12, 2019. 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.