Alma Lasers Accent Prime
RF body contouring · Ultrasound + unipolar RF
Technology: HIFU & Ultrasound
At a glance
- New price
- $80k–$120kSource not documented
- Used asking price
- $25k–$55kSource 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.
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Figures are reference points, not current offers. Used asking prices are not completed-sale values.
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–$120k. Reference figures, not current offers. Used asking prices are not completed-sale values.
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 | Ultrasound + unipolar RF |
| FDA status | FDA Cleared |
| 510(k) citation | K072699, K160075 |
| New price range | $80k–$120k |
| Used asking range | $25k–$55k |
| Consumables | Not published |
| Launch year | 2016 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Alma flagship body shaping platform
How it worksTechnology and manufacturing
How the technology works
Two modalities: cold shear-wave ultrasound (UltraSpeed/MiniSpeed plates) mechanically stressing and disrupting fat-cell membranes at low thermal load, and 40.68MHz unipolar RF (UniLarge/UniBody handpieces) bulk-heating dermis and subcutaneous tissue for circumference, cellulite-appearance, and laxity — protocol typically runs ultrasound first, RF second.
MicroPlasma Pixel RF tips add ablative fractional resurfacing on the same console. Cleared claims center on wrinkles, temporary cellulite-appearance reduction, and ultrasonic diathermy; "fat destruction" is where marketing outruns the label.
Courses run 4-8 weekly sessions per area; best on pinchable-fat, mild-moderate laxity patients with realistic expectations.
Patented technology
Alma's Unipolar RF at 40.68MHz is genuinely distinctive — single-electrode, no-return-pad architecture producing deep electromagnetic heating — and UltraSpeed's horizontal shear-wave (transverse) ultrasound is proprietary. Real engineering differences; thinly evidenced clinical superiority.
Origin
Caesarea, Israel (Alma Lasers / Sisram Medical); US operations Buffalo Grove, IL.
FDA & regulatory detailClearance timeline, authorization route and citation notes
Clearance 2007 · Launch 2016 · Clearance 2016 · K072699; K160075
Family/platform clearance: K072699 (Accent family incl. Accent XL, decision 5 Oct 2007) and K160075 (Accent XL console with ultrasound hand piece, 17 Aug 2016); no 510(k) naming Accent Prime was located. FDA's device listing carries Accent Prime (with vShape Ultra) under product codes NUV, ISA, IMI and GEI. Checked 8 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 — Ultrasound + unipolar RF
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.
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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
Supply pricing is not documented with a dated source yet. Request an itemized supply quote.
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 Lasers Accent Prime 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.
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ComplianceScreening and contraindications on the manufacturer's record
Contraindications & screening
Implanted electrical devices, pregnancy, metal implants in-field, active malignancy (diathermy label explicitly excludes treatment over malignancies), impaired sensation. Color-blind energy, safe across Fitzpatrick types.
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
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No confirmed chain deployments recorded yet.
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History4 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 8, 2026
FDA status
Unknown → Cleared
Source: Record correction
September 8, 2026
FDA K-numbers
K072699; K160075
Source: Record correction
September 8, 2026
FDA source URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K072699
Source: Record correction
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "Alma Lasers Accent Prime — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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