Data / Medical devices / United States / Solas Medical LLC
Solas Medical LLC: FDA-registered device maker in Dallas, TX, United States, 25 510(k) clearances
Solas Medical LLC is registered with the FDA (registration 3037874486) in Dallas, TX, United States. It lists 7 device types. The FDA files 25 510(k) clearances under its listings, the newest dated October 1, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3037874486
- Address
- 3355 Blackburn St Unit 5402, Dallas, TX, United States, 75204
- Owner or operator
- Solas Medical LLC (10093192)
- Roles
- Repackager or relabeler
- First device listed
- April 13, 2025
- Registered through
- 2026
- Brand names listed
- Solas 10600 FX, Solas CO2 Dragan, Solas IPL, Solas IPL Pro, Solas OmniPico, Solas QuadraDiode, Solas SonoSkin
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 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 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 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 |
|---|---|---|---|---|---|---|
| October 1, 2025 | K252447 | Picosecond laser device (BMPS4) | GEX | Substantially Equivalent | Hebei Newangie Technology Co., Ltd. | accessdata.fda.gov |
| June 9, 2025 | K250465 | CO2 Laser Machine (Lume) | GEX | Substantially Equivalent | Nanjing Bestview Laser S&T Co., Ltd. | accessdata.fda.gov |
| January 27, 2025 | K242941 | CO2 Laser Therapy Systems (SHE-LSP003-1) | GEX | Substantially Equivalent | Beijing Sano Laser S&T Development Co.,Ltd | accessdata.fda.gov |
| December 20, 2024 | K241670 | Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) | GEX | Substantially Equivalent | Beijing Adss Development Co., Ltd. | accessdata.fda.gov |
| November 14, 2024 | K242440 | Intense Pulsed Light Treatment System (LK-PT) | ONF | Substantially Equivalent | Nanjing Bestview Laser S&T Co., Ltd. | accessdata.fda.gov |
| September 25, 2024 | K241860 | Diode Laser Hair Removal System | GEX | Substantially Equivalent | Beijing Winkonlaser Technology Limited | accessdata.fda.gov |
| March 15, 2024 | K233307 | Intensity Pulsed Light Therapy System | ONF | Substantially Equivalent | Beijing Adss Development Co., Ltd. | accessdata.fda.gov |
| February 20, 2024 | K231896 | Diode Laser Therapy System | GEX | Substantially Equivalent | Beijing Adss Development Co., Ltd. | accessdata.fda.gov |
| October 13, 2022 | K211321 | Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) | IYN | Substantially Equivalent | Guangzhou Sonostar Technologies Co., Ltd. | accessdata.fda.gov |
| August 12, 2022 | K220385 | Intense Pulsed Light Equipment | ONF | Substantially Equivalent | Beijing Globalipl Development Co., Ltd. | accessdata.fda.gov |
| July 7, 2022 | K221246 | IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) | OHT | Substantially Equivalent | Shenzhen Semlamp Intelligent Technology Co., Ltd. | accessdata.fda.gov |
| February 1, 2022 | K212611 | CO2 Laser Equipment | GEX | Substantially Equivalent | Beijing Globalipl Development Co., Ltd. | accessdata.fda.gov |
| October 22, 2021 | K211735 | CO2 Laser Machine, Model: BW-203B | GEX | Substantially Equivalent | Zhengzhou Bestview ST Co., Ltd. | accessdata.fda.gov |
| April 7, 2021 | K203491 | PicoLO Nd: YAG Picosecond Laser System | GEX | Substantially Equivalent | Laseroptek Co., Ltd. | accessdata.fda.gov |
| July 15, 2020 | K201109 | CO2 Laser Therapy System | GEX | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
| June 9, 2020 | K200042 | CO2 Laser System | GEX | Substantially Equivalent | Beijing Superlaser Technology Co., Ltd. | accessdata.fda.gov |
| May 28, 2020 | K200116 | PicoSecond Nd: YAG Laser System | GEX | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 15, 2020 | K200746 | IPL Treatment Systems | ONF | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 17, 2020 | K200118 | Diode Laser Therapy Device | GEX | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 13, 2020 | K193464 | ND:YAG Laser | GEX | Substantially Equivalent | Beijing Superlaser Technology Co., Ltd. | accessdata.fda.gov |
| December 3, 2019 | K192528 | CO2 Laser Therapy System | GEX | Substantially Equivalent | Shangdong Huamei Technology Co., Ltd. | accessdata.fda.gov |
| July 6, 2017 | K162398 | CO2 Laser Therapy Systems | ONG | Substantially Equivalent | Beijing Sincoheren Science and Technology Development Co. | accessdata.fda.gov |
| June 16, 2017 | K162659 | Diode Laser Hair Removal System | GEX | Substantially Equivalent | Shandong Huamei Technology Co., Ltd. | accessdata.fda.gov |
| August 4, 2016 | K161286 | IPL Therapy Machine | ONF | Substantially Equivalent | Beijing Adss Development Co., Ltd. | accessdata.fda.gov |
| January 23, 2014 | K132989 | SPEED 808 DIODE LASER SYSTEM | GEX | Substantially Equivalent | Beijing Toplaser Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Powered Laser Surgical Instrument
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Light Based Over-The-Counter Hair Removal
Updated October 1, 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.