truFlex vs Pure Impact (2026)

New price range

Cutera truFlex (flex+)

Not published

Sofwave Pure Impact

Not published

Payback calculator

Cutera truFlex (flex+)

View cost details

Sofwave Pure Impact

View cost details

Supplies & restrictions

Cutera truFlex (flex+)

Requires Cutera cycle refills plus single-use truGel hydrogel pads — both booked as consumable revenue in Cutera's 10-K.

Manufacturer-provided · Aug 31, 2026

Supply restrictions: card-metered — license cards or dongles gate treatments

View running-cost details

Sofwave Pure Impact

Supply details not yet documented.

View running-cost details

FDA status & indication

Cutera truFlex (flex+)

FDA ClearedK251594, K212866

Read FDA indication wording

“truFlex is indicated to be used for: • Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. • Strengthening, toning and firming of arms, buttocks, thighs, and calves • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Maintaining or increasing range of motion • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis • Stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes • To be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions The device safety and efficacy was demonstrated by performance data and a comparison of technical characteristics between the modified device and the predicate device.”

Sofwave Pure Impact

FDA ClearedK251746

Read FDA indication wording

“Pure Impact is indicated to be used for: • Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. • Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas. • The Pure Impact is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Pure Impact is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The various types of muscle work that the Pure Impact can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Pure Impact may therefore be considered a technique of muscle training. The indications for use statement for the subject device is identical to that of the previously cleared Pure Impact Module of the SofWave System in K250146.”

Chain adoption

Cutera truFlex (flex+)

0 recorded pairings

Sofwave Pure Impact

0 recorded pairings

Chains using it

Cutera truFlex (flex+)

—

Sofwave Pure Impact

—

Approved reviews

Cutera truFlex (flex+)

0

Sofwave Pure Impact

0

Manufacturer

Cutera truFlex (flex+)

Cutera

Sofwave Pure Impact

Sofwave

Built by (OEM)

Cutera truFlex (flex+)

Cutera Inc.

Sofwave Pure Impact

Sofwave Medical Ltd.

Category

Cutera truFlex (flex+)

Body Contouring

Sofwave Pure Impact

Body Contouring

Technology

Cutera truFlex (flex+)

Multi-directional EMS (EMS / muscle stimulation)

Sofwave Pure Impact

Electrical muscle stimulation (PlyoPulse) (EMS / muscle stimulation)

Launch year

Cutera truFlex (flex+)

2023

Sofwave Pure Impact

—

Status

Cutera truFlex (flex+)

Current

Sofwave Pure Impact

Current

Manufacturing relationship evidence

Cutera truFlex (flex+)

No separate manufacturing-relationship record linked.

Sofwave Pure Impact

No separate manufacturing-relationship record linked.