Cynosure SculpSure
Laser fat reduction (external) · 1060nm diode hyperthermic lipolysis
Technology: Diode Laser
At a glance
- New-unit reference · older model
- $100k–$165kSource not documented
- Used asking price
- $15k–$40kSource 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. Used asking prices are not completed-sale values.
Read FDA-cleared indicationsExact wording from 4 FDA records
K150724 (Cynosure, Inc., 2015)
The Cynosure SculpSure is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K160470 (Cynosure, Inc., 2016)
Cynosure SculpSure is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen and flanks.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K171992 (Cynosure, Inc., 2017)
The Cynosure SculpSure™ is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a BMI of 43 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K182741 (Cynosure, 2019)
The Cynosure SculpSure™ is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a BMI of 49 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area. When using the petite mask for non-invasive lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: August 6, 2026 · How we verify
Axis runs $0–$165k. 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 | Cynosure |
|---|---|
| Company | Owner: Hahn & Company (South Korean private equity) (private equity owned, since 2024) · Distribution: direct |
| Parent company | Cynosure Lutronic |
| Brand owner | Cynosure |
| Built by (OEM) | Cynosure LLC |
| Category | Body Contouring |
| Technology | 1060nm diode hyperthermic lipolysis |
| FDA status | FDA Cleared |
| 510(k) citation | K150724, K160470, K171992, K182741 |
| New-unit reference (older model) | $100k–$165k |
| Used asking range | $15k–$40k |
| Consumables | Not published |
| Launch year | 2015 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
25-minute flat applicators, de-emphasized by Cynosure
How it worksTechnology and manufacturing
How the technology works
The 1060nm wavelength has selective affinity for adipose tissue and penetrates deep with minimal melanin absorption, making it safe across all Fitzpatrick types. Applicators heat subcutaneous fat to 42-47C for 25 minutes, inducing adipocyte apoptosis; damaged fat cells clear via the lymphatic system over 6-12 weeks.
Pivotal data showed roughly 24% fat-layer reduction per treatment by ultrasound measurement. Continuous contact cooling keeps the dermis comfortable, and unlike cryolipolysis there is no documented risk of paradoxical adipose hyperplasia.
Patented technology
Cynosure's patented flat non-suction applicator frame system templating up to four applicators simultaneously — genuinely hands-free. The 1060nm hyperthermic lipolysis approach was a deliberate patent design-around of Zeltiq's cooling IP.
Origin
Westford, Massachusetts, USA (Cynosure, now Cynosure Lutronic).
FDA & regulatory detailClearance timeline, authorization route and citation notes
FDA-cleared indications (verbatim)
K150724 (Cynosure, Inc., 2015)
The Cynosure SculpSure is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K160470 (Cynosure, Inc., 2016)
Cynosure SculpSure is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen and flanks.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K171992 (Cynosure, Inc., 2017)
The Cynosure SculpSure™ is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a BMI of 43 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K182741 (Cynosure, 2019)
The Cynosure SculpSure™ is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a BMI of 49 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area. When using the petite mask for non-invasive lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
Diode laser — 1060nm diode hyperthermic lipolysis
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: Cynosure Lutronic
Legal manufacturer: Cynosure LLC (United States)
Applicant on the FDA record
Cynosure, Inc.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.
Treatment & running costs
Treatments
Sessions & timing
No treatment schedule documented yet.
What practices charge
No sourced treatment price on file.
Supplies & recurring costs
None — no cycle cards, no gel pads, no per-treatment fees; only inexpensive applicator frames and straps. Always SculpSure's quiet economic advantage over CoolSculpting's card model.
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 Cynosure SculpSure 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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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.
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Provider or tech time for one treatment, fully loaded. Enter 0 if you own-operate.
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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
Pregnancy, active skin conditions or infection at the site, caution over tattoos in the zone (1060nm absorbs in dark ink). Not for significant visceral adiposity or weight-loss 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.
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Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
History2 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
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, "Cynosure SculpSure — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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