InMode

Summary

37 relevant published 510(k) records were found under InMode, InMode MD and Invasix. Of these, 13 decisions were mapped to the current families shown here; the remaining 24 are retained as unresolved current-portfolio mappings and excluded from the current-portfolio metric. Successive decisions and shared applicators are not separate product counts. ^[81][108]

Recent directly matched decisions include K251254 for Ignite RF (January 15, 2026), K251632 for Optimas MAX (June 26, 2025) and K242598 for Define. Earlier Morpheus8 and VTone decisions apply to their specified configurations and indications. The manufacturer states Morpheus8MAX’s Erbia module is pending FDA approval. Cool-specific linkage remains unresolved; existing RF decisions do not establish clearance of every new configuration or EmpowerRF treatment claim. ^{[77][78][76][72][64]}

Exact current-platform FDA linkage remains unresolved for ApexRF, Luxora, Solaria and Picofy. This is a documentation gap, not a finding that the products lack authorization. Manufacturer and OEM labeling may be needed to reconcile trade names and modules. ^{[83][88][92][91]}

FDA’s October 15, 2025 RF-microneedling safety communication discusses reported burns, scarring, fat loss, disfigurement and nerve damage with certain uses. It is a category-level communication, not a brand-specific recall or a determination that any individual report proves causation. ^[80]

Published FDA searches under the company and selected product names found no relevant original PMA approvals, De Novo grants or recall events. Unrelated name matches are excluded. ^{[41][39][40][79]}