Jeisys ULTRAcel
HIFU/Ultrasound Lifting · HIFU + fractional RF + RF microneedling combo
Technology: HIFU & Ultrasound
Classification & configurations
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
At a glance
- New-unit reference · older model
- Not published
- Used asking price
- $8k–$18kSource not documented
- FDA status
- Supplies & recurring costs
- Supply details not yet documented.
Sources and verified data on file
Data on file
- Recurring consumables
- Not verified
- FDA
- No US 510(k) located — checked 4 Sep 2026
- 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.
Page updated: September 7, 2026 · How we verify
No new-unit price reference is published for this older model.
Axis runs $0–$18k. 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 | Jeisys |
|---|---|
| Company | Owner: Archimed SAS (French healthcare private equity, via MED Platform II) (private equity owned, since 2024) · Distribution: hybrid (direct + distributor) |
| Parent company | ARCHIMED |
| Brand owner | Jeisys |
| Built by (OEM) | Jeisys Medical Inc. |
| Category | HIFU/Ultrasound Lifting |
| Technology | HIFU + fractional RF + RF microneedling combo |
| FDA status | No US 510(k) located |
| New-unit reference (older model) | Not published |
| Used asking range | $8k–$18k |
| Consumables | Not published |
| Launch year | 2015 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Early HIFU/RF-microneedling hybrid; no US 510(k) located for this model.
FDA & regulatory detailClearance timeline, authorization route and citation notes
No US 510(k) was located for this model (checked 4 Sep 2026). Lenders and insurers may ask for regulatory documentation before financing or covering a device without US clearance.
FDA-cleared indications (verbatim)
Not published — no US clearance located for this model.
Marketed for
HIFU / Ultrasound — HIFU + fractional RF + RF microneedling combo
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: ARCHIMED
Legal manufacturer: Jeisys Medical Inc. (South Korea)
Regulatory data comes from public FDA records and may lag recent updates. Confirm the applicable status and documentation before purchase.
FDA safety actions
Recorded recalls, warning letters and safety communications. Terminated actions remain visible as history.
How we report safety actionsChecked 7 Sep 2026 against FDA enforcement data dated 2 Sep 2026.
- FDA safety communicationFDA safety communication, issued 15 October 2025Open
Initiated Oct 15, 2025
Scope as FDA lists it
Applies to RF microneedling devices used for dermatologic or aesthetic procedures intended to improve the appearance of the skin. FDA is aware of reports of burns, scarring, fat loss, disfigurement and nerve damage, and of injuries needing surgical repair.
FDA advises providers to discuss these risks with patients and to report complications.
Reason and action
FDA advises providers to discuss these risks with patients before treatment, to use devices only as cleared, and to report complications to MedWatch. FDA did not name individual brands; the communication covers 510(k)-cleared RF microneedling devices as a class.
This communication applies to a class of devices, not to a specific unit or recall.
This is an FDA communication about a device class, not a recall of specific units; read the FDA notice for the reported risks and FDA's recommendations.
Manufacturer response: none on file — manufacturers can reply via their company profile.
FDA record
Look-alike devices
Comparing an unbranded RF microneedling unit? Check the exact model rather than relying on similar photos or treatment claims.
Listed manufacturer for this profile: Jeisys Medical 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
Consumable costs are not documented yet.
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 Jeisys ULTRAcel 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 used asking 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.
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.
History3 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 7, 2026
parent company
Jeisys → ARCHIMED
Ultimate owner updated against a dated primary source (8 Sep 2026).
Source: https://www.archimed.group/news/archimed-acquires-jeisys-medical-a-leading-developer-of-aesthetic-medicine-devices/
September 4, 2026
FDA indication
No ULTRAcel 510(k) in Jeisys US record; circulates on US used market → No 510(k) naming this model was located (checked 4 Sep 2026).
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, "Jeisys ULTRAcel — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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