Data / Medical devices / United States / Emvera Technologies, LLC
Emvera Technologies, LLC: FDA-registered device maker in Aragon, GA, United States, 5 510(k) clearances
Emvera Technologies, LLC is registered with the FDA (registration 3009019578) in Aragon, GA, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 23, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009019578
- Address
- 2550 Rome Hwy, Aragon, GA, United States, 30104
- Owner or operator
- Emvera Technologies, LLC (10040962)
- Roles
- Repackager or relabeler
- First device listed
- June 5, 2024
- Registered through
- 2026
- Brand names listed
- Aesthelite Plus, Aurelia 1927, ClarO2, Diolux Quad, Illumerase Pro
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 |
|---|---|---|---|---|---|---|
| October 23, 2025 | K252732 | 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) | GEX | Substantially Equivalent | Zhengzhou PZ Laser Slim Technology Co., Ltd. | accessdata.fda.gov |
| May 14, 2025 | K250041 | Medical Picosecond ND: YAG Laser System (PZ-6) | GEX | Substantially Equivalent | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 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 5, 2016 | K161925 | CO2 Laser Therapy Machine | GEX | Substantially Equivalent | Beijing Adss Development Co., Ltd. | 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 October 23, 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.