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InMode-linked TONE-PRO pilot reports preliminary gluteal EMS findings

Source publication date

Site published

Twenty adults received ten weekly TONE-PRO treatments. Ultrasound thickness rose about 2 mm at one-month follow-up. The paper identifies InMode; its education site associates the study with Tone/EvolveX. This was electrical EMS, not HIFEM or RF. FDA K201285 lists Tone’s muscle/nerve indications; K231495 separately covers Transform’s sequential RF/EMS abdominal lipolysis and circumference reduction.

Summary

A small study examines muscle thickness rather than weight loss.

Editorial view

Editorial view: objective imaging is useful, but controlled replication is needed.

Evidence and limitations

Single-arm pilot, no sham control, short follow-up and no strength assessment. Thickness does not establish durable hypertrophy, fat loss or obesity treatment. The paper’s TONE-PRO-to-US-device configuration mapping remains unverified; Transform’s clearance cannot be transferred to this protocol.

Sources

Journal of Cosmetics, Dermatological Sciences and Applications

Journal of Cosmetics, Dermatological Sciences and Applications

InMode University

FDA

FDA