At a glance
- New price
- $100k–$160kSource not documented
- FDA status
- Supplies & recurring costs
- See supply and replacement costs below.
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.
Read FDA-cleared indicationsExact wording from 2 FDA records
K072699 (Alma Lasers, Ltd., 2007)
The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is intended for use in dermatologic and general surgical procedures. The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is indicated for the noninvasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K160075 (Alma Lasers, Inc., 2016)
The Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatological and general surgical procedures. The Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar hand pieces. The massage component of the Alma Lasers Accent Uniform Hand piece is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide: -Temporary reduction in the appearance of cellulite. Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide: -Temporary reduction in the appearance of cellulite. The Unipolar and Bipolar hand pieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids. The Pixel RF Tips (stationary and rolling), when used with the unipolar hand piece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin. Ultrasound Module provides ultrasonic diathermy intended for: • Relief of pain • Muscle spasms • Joint contractures • NOT for the treatment of malignancies The hand pieces above are intended to be used with the console cleared in K101147 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite].
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: September 8, 2026 · How we verify
Axis runs $0–$160k. Reference figures, not current offers.
Not verified
We hold no per-treatment consumable price for this device from a dated source. Ask the seller for a written per-treatment cost.
Price sourcesSources, dates and configurations
Key factsCompany, specifications and verification dates
| Manufacturer | Alma Lasers |
|---|---|
| Company | Owner: Sisram Medical Ltd (HKEx: 1696), controlled by Shanghai Fosun Pharmaceutical (subsidiary, since 2013) · Distribution: direct |
| Parent company | Alma (Sisram Medical) |
| Brand owner | Alma Lasers |
| Built by (OEM) | Alma Lasers Ltd. |
| Category | Body Contouring |
| Technology | High-power RF + ultrasound |
| FDA status | FDA Cleared |
| 510(k) citation | K072699, K160075 |
| New price range | $100k–$160k |
| Used asking range | Not published |
| Consumables | Not published |
| Launch year | 2022 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Large-area next-gen Accent successor
How it worksTechnology and manufacturing
How the technology works
The ultrasound applicator delivers transverse (shear) acoustic waves that selectively stress adipocyte membranes — mechanical, non-thermal fat disruption sparing vessels, nerves, dermis.
The unipolar RF handpieces at 40.68MHz generate deep dielectric heating to 45C+ in fat and dermal layers, driving collagen remodeling, tightening, and circumferential reduction. Combining both in one protocol attacks fat volume and laxity in the same visit — the platform's clinical thesis.
Protocols: 4-6 weekly sessions per area, results over 8-12 weeks.
Patented technology
Alma's patented cold shear-wave ultrasound delivery (UltraSpeed large flat transducer) and long-standing unipolar RF architecture — one-electrode deep heating without a return pad — inherited and up-powered from the Accent lineage.
Origin
Caesarea, Israel (Alma Lasers, Sisram Medical).
FDA & regulatory detailClearance timeline, authorization route and citation notes
Family/platform clearance: K072699 and K160075 name the Accent and Accent XL; no 510(k) naming Alma PrimeX was located (checked 4 Sep 2026).
FDA-cleared indications (verbatim)
K072699 (Alma Lasers, Ltd., 2007)
The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is intended for use in dermatologic and general surgical procedures. The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is indicated for the noninvasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K160075 (Alma Lasers, Inc., 2016)
The Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatological and general surgical procedures. The Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar hand pieces. The massage component of the Alma Lasers Accent Uniform Hand piece is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide: -Temporary reduction in the appearance of cellulite. Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide: -Temporary reduction in the appearance of cellulite. The Unipolar and Bipolar hand pieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids. The Pixel RF Tips (stationary and rolling), when used with the unipolar hand piece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin. Ultrasound Module provides ultrasonic diathermy intended for: • Relief of pain • Muscle spasms • Joint contractures • NOT for the treatment of malignancies The hand pieces above are intended to be used with the console cleared in K101147 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite].
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
HIFU / Ultrasound — High-power RF + ultrasound
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: Alma (Sisram Medical)
Legal manufacturer: Alma Lasers Ltd. (Israel)
Applicant on the FDA record
Alma Lasers Ltd.The 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 HIFU (focused ultrasound) unit? Check the exact model rather than relying on similar photos or treatment claims.
Listed manufacturer for this profile: Alma Lasers Ltd.
- 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
Effectively none — ultrasound gel and routine applicator upkeep; no cards, tips or cycle fees.
Annual service & support
No annual service cost documented yet.
Payback calculatorModel your own volume, labor and service costs
Estimate your payback
Pre-filled from our published Alma PrimeX data where we have it. Estimates appear once the required inputs are available. Review and adjust every pre-filled value before relying on the result.
Start from
No verified per-treatment supply cost is on file. Enter your own allowance. Use $0 only if you have confirmed that it applies to your practice.
Pre-filled from the midpoint of the published new-price range
20 is an illustrative default — change it to your volume.
No sourced per-session price on file — enter what you charge.
Required — enter your cost; missing data does not mean $0.
Provider or tech time for one treatment, fully loaded. Enter 0 if you own-operate.
Annual service contract ÷ 12, if you carry one.
Your estimate
Enter price you charge per treatment, consumable cost per treatment to see contribution and a payback range.
This model ignores financing — if you lease or borrow, add your monthly payment. Estimates from your inputs and our published ranges — not a projection, guarantee or financial advice. How we calculate this.
ComplianceScreening and contraindications on the manufacturer's record
Contraindications & screening
Pacemakers/ICDs and metal implants in the field for RF, pregnancy, active malignancy, impaired sensation; avoid ultrasound over bony prominences and recently augmented areas. Not for high-BMI debulking expectations.
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.
History6 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 8, 2026
consumables detail
Catalog update — superlatives, margin judgements and unsourced dollar claims removed (neutral-voice standard, 8 Sep 2026)
Source: Editorial standard
September 4, 2026
FDA K-numbers
Source: Catalog update
September 4, 2026
FDA source URL
Source: Catalog update
September 4, 2026
510(k) numbers
K-number set re-verified against openFDA
Source: Council round 2 audit, verified on openFDA 2026-09-04
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, "Alma PrimeX — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
Get the full State of Aesthetic Devices 2026 report
A catalog of US-marketed aesthetic and wellness devices — preview it free.
Device and company names are trademarks of their respective owners. The Aesthetic Index is not affiliated with or endorsed by any manufacturer, distributor or lender named here, except as disclosed. Price figures are references, not current offers. Check each device’s source notes. Not medical, legal or regulatory advice.