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Asclepion MeDioStar (monolith)

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Diode laser · 810/940nm diode, 10cm2 handpiece

Technology: Diode Laser

Classification & configurations

Category group: Hair removal (diode, alexandrite, Nd:YAG, IPL)

Also sold as / variants: MeDioStar NeXT PRO — applicator and configuration variants of the same platform, covered on this page.

Current

At a glance

New price
$80k–$110kSource not documented
Used asking price
$45k–$70kSource not documented
FDA status
Supplies & recurring costs
See supply and replacement costs below.
View supply details
Sources and verified data on file

Data on file

Recurring consumables
Not verified
FDA
FDA ClearedK192483
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 1 FDA record

K192483 (Asclepion Laser Technologies GmbH, 2020)

The MeDioStar laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology. The MeDioStar laser system is intended for the treatment of benign vascular lesions. The MeDioStar laser system is intended for the treatment of benign pigmented lesions. The MeDioStar laser system is intended for hair removal, permanent hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months. Description of the modifications: This Special 510(k) of MeDioStar is submitted due to Device Modifications of the already cleared device The MeDioStar NeXT Family (K143519) due to some technical modifications.

Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.

Page updated: August 6, 2026 · How we verify

New and used price references
New$80k–$110k
Source not documented
Used$45k–$70k
Source not documented

Axis runs $0–$110k. Reference figures, not current offers. Used asking prices are not completed-sale values.

Consumable cost per treatment

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
New: $80k–$110k·Researched estimate — no dated source on file yet; not a quote.
Used asking range: $45k–$70k·Researched estimate — no dated source on file yet; not a quote.
Key factsCompany, specifications and verification dates
Key facts
ManufacturerAsclepion
CompanyNot published
Parent companyAsclepion
Brand ownerAsclepion
Built by (OEM)Asclepion Laser Technologies GmbH
CategoryDiode laser
Technology810/940nm diode, 10cm2 handpiece
FDA statusFDA Cleared
510(k) citationK192483
New price range$80k–$110k
Used asking range$45k–$70k
ConsumablesNot published
Launch year2019
PricingNot published
Manufacturer-source documents checkedNot published

Overview

Current MeDioStar generation

How it worksTechnology and manufacturing

How the technology works

Simultaneous 810nm and 940nm emission balances melanin absorption against penetration depth — 810 does the classic follicle heating while 940 reaches deeper bulbs and the vascular supply to the papilla. High repetition with shortened pulses enables true in-motion technique across Fitzpatrick I-VI.

The physics advantage of the giant 10cm2 aperture isn't just speed: larger spots reduce scatter losses at depth, delivering more effective fluence to the follicle at lower surface settings.

Patented technology

The Monolith handpiece line with integrated Peltier skin cooling and 360-degree contact cooling around the full aperture, alongside the dual-wavelength simultaneous emission architecture; the 10cm2 XL aperture remains a category-defining spec no major competitor matches.

Origin

Jena, Germany — Asclepion Laser Technologies GmbH, rooted in the Zeiss optical tradition.

FDA & regulatory detailClearance timeline, authorization route and citation notes
Documented clearance timeline
Documented dates: Launch 2019, Clearance 202020192020

Launch 2019 · Clearance 2020 · K192483

Authorized via 510(k)

FDA-cleared indications (verbatim)

K192483 (Asclepion Laser Technologies GmbH, 2020)

The MeDioStar laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology. The MeDioStar laser system is intended for the treatment of benign vascular lesions. The MeDioStar laser system is intended for the treatment of benign pigmented lesions. The MeDioStar laser system is intended for hair removal, permanent hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months. Description of the modifications: This Special 510(k) of MeDioStar is submitted due to Device Modifications of the already cleared device The MeDioStar NeXT Family (K143519) due to some technical modifications.

Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.

Marketed for

Diode laser — 810/940nm diode, 10cm2 handpiece

Marketing claims are the manufacturer's own and are not the same as a cleared indication.

510(k) numbers

K192483

Parent company: Asclepion

Legal manufacturer: Asclepion Laser Technologies GmbH (Germany)

Applicant on the FDA record

Asclepion Laser Technologies GmbHThe 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

No per-pulse consumables — fixed-cost once purchased. Handpieces are the long-term wear item; ask Astanza for diode stack lifetime ratings and refurbishment pricing upfront.

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 Asclepion MeDioStar (monolith) 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

Pregnancy, recent UV or tanning-bed exposure, photosensitizers, active herpes or bacterial infection in the field, tattoos and permanent makeup in the area; non-pigmented hair won't respond, and fine vellus hair responds poorly on any diode.

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 review

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Current alternatives

Current catalog models to research. Confirm availability and configuration with the supplier.

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Research comparisons

Includes current and older models.

History2 tracked changes

Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.

  1. August 5, 2026

    Warranty & service

    Source: Catalog update

  2. August 1, 2026

    Record created

    Added to The Aesthetic Index — August 2026

    Source: The Aesthetic Index editorial

Cite this data: The Aesthetic Index, "Asclepion MeDioStar (monolith) — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).

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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.