Data / Medical devices / Powered Light Based Non-Laser Surgical Instrument With Thermal Effect / United States
FDA-registered makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (product code ONF). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- Product code
- ONF
- Country
- United States
Makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Venus Concept Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | September 11, 2023 | 0 | 0 | 0 | api.fda.gov |
| Venus Concept Inc. | Windham, NH, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | September 11, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medicreations LLC | Las Vegas, NV, United States | Manufacturer, Repackager or relabeler | 2 | September 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Aesthetic Protools, Inc. | Scottsdale, AZ, United States | Repackager or relabeler, Specification developer | 1 | December 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Solta Medical, Inc. | Bothell, WA, United States | Manufacturer, Remanufacturer | 1 | June 5, 2012 | 0 | 0 | 0 | api.fda.gov |
| Strata Skin Sciences, inc. | Carlsbad, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | March 4, 2013 | 0 | 0 | 0 | api.fda.gov |
| Candela Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sciton, Inc. | Palo Alto, CA, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| World Aesthetix LLC | Jacksonville, FL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.