Data / Medical devices / United States / C3 Select LLC
C3 Select LLC: FDA-registered device maker in Carrollton, TX, United States, 5 510(k) clearances
C3 Select LLC is registered with the FDA (registration 3042953831) in Carrollton, TX, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 17, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042953831
- Address
- 1001 W. Crosby Rd, Carrollton, TX, United States, 75006
- Owner or operator
- C3 Select LLC (10094667)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- December 15, 2025
- Registered through
- 2026
- Brand names listed
- 808 Diode Laser, EMS Body Sculpting Device, IPL Laser, RF Microneedling Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| September 17, 2024 | K242186 | Neo Sculptor (OF-NEO001) | NGX | Substantially Equivalent | Ofan Intelligent Technology (Guangzhou) Co. , Ltd. | accessdata.fda.gov |
| October 19, 2023 | K231749 | Radio Frequency System | GEI | Substantially Equivalent | Shenzhenshi Sincoheren S&T Development Co., Ltd. | accessdata.fda.gov |
| April 6, 2020 | K191970 | Diode Laser Hair Removal System | GEX | Substantially Equivalent | Beijing Sano Laser S&T 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 |
| April 24, 2014 | K131838 | DIODE LASER FOR HIAR REMOVAL | GEX | Substantially Equivalent | Beijing Honkon Technologies Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated September 17, 2024. 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.