BRANDS
Solta Medical
Follow each brand to the devices and source documents collected here.
Role in the reviewed material
Documented role: Manufacturer. The linked regulatory or manufacturer material is filed under this company for the devices listed above.
About this collection
This collects the device records reviewed so far, not a complete product portfolio. Follow a device for its individual specifications and outstanding verification work.
Related articles
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Four hundred watts and 115 watts. Those two figures sit side by side in the comparison table of FDA 510(k) summary K240248, one column for the predicate…
Monopolar RF Devices Compared: Why Thermage, Volnewmer and Oligio All Use 6.78 MHz
Thermage FLX and Korea's Volnewmer list the same radiofrequency. Reading the 510(k) records and manufacturer specifications shows where the shared number stops explaining anything.
Volnewmer vs Oligio: What Their FDA Filings Share and Where They Differ
Wontech's Oligio and Classys's Volnewmer both run 6.78MHz monopolar radiofrequency, and both cite the same predicate device in their US 510(k) filings. Line…
Sources reviewed
- Thermage FLX — Solta Medical (Canada) ↗Manufacturer material · Accessed 2026-09-08
- FDA 510(k) K170758 — Thermage FLX System and Accessories (Solta Medical) ↗Regulatory record · Accessed 2026-09-09