Cutera truFlex (flex+)
EMS/HIFEM muscle stimulation · Multi-directional EMS
Technology: EMS & Muscle Stimulation
At a glance
- New price
- Not published
- FDA status
- Supplies & recurring costs
- Requires Cutera cycle refills plus single-use truGel hydrogel pads — both booked as consumable revenue in Cutera's 10-K.
Sources and verified data on file
Data on file
- Recurring consumables
- Not verified
- Used asking prices
- Not verified
- This panel shows a per-treatment supply cost only when a recorded figure has a dated source.
- Bottle prices and estimates may still appear under Treatment & running costs.
- The calculator may include a labeled planning estimate. Review it or enter your own allowance; missing data never means $0.
Figures are reference points, not current offers.
Manufacturer-source documents checked: August 31, 2026
Read FDA-cleared indicationsExact wording from 2 FDA records
K251594 (Syrma Johari Medtech Limited, 2025)
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.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K212866 (Johari Digital Healthcare Limited, 2022)
truSculpt flex 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 buttocks & thighs.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: September 23, 2026 · How we verify
New-equipment price not yet documented
For a complete budget, ask for an itemized quote covering the device, accessories, training and service.
Price sourcesSources, dates and configurations
No price sources are documented yet. Ask the seller for a current, itemized quote.
Key factsCompany, specifications and verification dates
| Manufacturer | Cutera |
|---|---|
| Company | Owner: Private company (since 2025) · Distribution: direct |
| Parent company | Cutera |
| Brand owner | Cutera |
| Built by (OEM) | Cutera Inc. |
| Category | Body Contouring |
| Technology | Multi-directional EMS |
| FDA status | FDA Cleared |
| 510(k) citation | K251594, K212866 |
| New price range | Not published |
| Used asking range | Not published |
| Consumables | Requires Cutera cycle refills plus single-use truGel hydrogel pads — both booked as consumable revenue in Cutera's 10-K. |
| Launch year | 2023 |
| Pricing | Not published |
| Manufacturer-source documents checked | August 31, 2026 |
Overview
Rebranded/upgraded flex, sold in truBody bundle with truSculpt iD
How it worksTechnology and manufacturing
How the technology works
Multi-Directional Stimulation (MDS) — proprietary EMS waveforms cycling through twisting, prep, and sculpt patterns to contract muscles beyond voluntary exercise, claiming up to 30% average muscle mass increase in treated areas.
Sixteen small conformable applicators strap onto up to eight muscle groups simultaneously (abs, glutes, thighs, arms, calves), with 15-45 minute protocols calibrated to patient fitness.
Unlike HIFEM, EMS current passes through skin via gel-pad electrodes — stronger surface sensation but targeted, per-zone-adjustable energy. Builds and firms muscle; does not meaningfully reduce fat.
Patented technology
Patented MDS waveform technology mimicking twisting/crunch movement patterns rather than a single repetitive contraction; the multi-applicator architecture for simultaneous multi-zone treatment is the key differentiator from coil-based HIFEM.
Origin
Brisbane, California, USA (Cutera).
FDA & regulatory detailClearance timeline, authorization route and citation notes
OEM clearance: K251594 (truFlex, Syrma Johari Medtech Limited, decision 28 Aug 2025) and K212866 (truSculpt flex, Johari Digital Healthcare Limited, 3 Dec 2022) — the manufacturer's records; FDA's device listing carries truFlex under both Syrma Johari MedTech and Cutera. Checked 8 Sep 2026.
FDA-cleared indications (verbatim)
K251594 (Syrma Johari Medtech Limited, 2025)
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.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K212866 (Johari Digital Healthcare Limited, 2022)
truSculpt flex 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 buttocks & thighs.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
EMS / muscle stimulation — Multi-directional EMS
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
510(k) holder of record
510(k) holder of record: Johari Digital Healthcare Limited — Cutera markets, supports and warranties the device in the US.
Parent company: Cutera
Legal manufacturer: Cutera Inc. (United States)
Applicant on the FDA record
Syrma Johari Medtech LimitedThe applicant named on the FDA record can differ from the brand shown on the device.
Regulatory data comes from public FDA records and may lag recent updates. Confirm the applicable status and documentation before purchase.
Look-alike devices
Comparing an unbranded HIFEM / electromagnetic muscle-stimulation unit? Check the exact model rather than relying on similar photos or treatment claims.
Listed manufacturer for this profile: Cutera Inc.
- FDA record: Match any claimed 510(k) or De Novo number to the exact model and applicant in the FDA database.
- Support: Get written warranty, training, consumables and service terms from the seller.
- Financing: Confirm availability for the exact unit before including it in your budget.
We do not profile these unbranded units or verify their support and financing terms. This profile’s FDA record applies to the named device, not every similar-looking unit.
Treatment & running costs
Treatments
Sessions & timing
No treatment schedule documented yet.
What practices charge
No sourced treatment price on file.
Supplies & recurring costs
Requires Cutera cycle refills plus single-use truGel hydrogel pads — both booked as consumable revenue in Cutera's 10-K.
- Vendor restrictions: card-metered — license cards or dongles gate treatments
Annual service & support
No annual service cost documented yet.
ComplianceScreening and contraindications on the manufacturer's record
Contraindications & screening
No metal or electronic implants in the field (pacemakers, defibrillators, copper IUDs for abdominal work), pregnancy, active hernias, malignancy, epilepsy; recent surgery in the area is a hard stop.
Warranty & serviceWhat to confirm in writing before you buy
Before buying new or used, confirm in writing:
- Current warranty coverage
- Included training
- Service terms
Chains using this device
A chain listing does not establish availability at every location.
No confirmed chain deployments recorded yet.
Owner & operator reviews
Write a reviewNo owner or operator reviews yet. Be the first →
Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
Sofwave Pure Impact
EMS/HIFEM muscle stimulation
New-equipment price not yet documented.
History10 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 23, 2026
New price range
100000-160000 → —
Source: Catalog update
September 23, 2026
Price evidence review
{"new_price_range": "100000-160000", "used_price_range": null} → {"new_price_range": null, "used_price_range": null}
Withheld unsupported price ranges after reviewing catalog sources, price history and primary product pages on September 23, 2026. No price provenance or price-change evidence establishes these condition-specific ranges. Cutera product pages request inquiries without publishing a purchase price. Other listings do not establish this range, condition, configuration or completed-sale value. Original values are preserved here; this is not a claim that a market price cannot be established. Non-price sources, device facts, reviews and commercial status remain unchanged.
Source: https://cutera.com/us-en/products/truflex/
September 8, 2026
FDA status
Unknown → Cleared
Source: Record correction
September 8, 2026
FDA K-numbers
K251594; K212866
Source: Record correction
September 8, 2026
FDA source URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251594
Source: Record correction
September 7, 2026
Warranty & service
Catalog update — editorial sentences removed (neutral-voice standard, 7 Sep 2026)
Source: Editorial standard
September 7, 2026
Warranty & service
Catalog update — editorial sentences removed (neutral-voice standard, 7 Sep 2026)
Source: Editorial standard
August 5, 2026
FDA indication
Source: Catalog update
August 5, 2026
Warranty & service
Source: Catalog update
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "Cutera truFlex (flex+) — pricing, FDA status and cost to own", aestheticindex.co (accessed September 25, 2026).
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