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Fotona StarWalker PQX

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Picosecond Tattoo/Pigment · Pico/nano adaptive QS Nd:YAG

Technology: Nd:YAG Laser

Classification & configurations

Category group: Resurfacing & pigment (ablative, fractional, picosecond, vascular)

Current

At a glance

New price
$100k–$150kSource not documented
Used asking price
$60k–$90kSource not documented
FDA status
Supplies & recurring costs
Supply details not yet documented.
View supply details
Sources and verified data on file

Data on file

Recurring consumables
Not verified
FDA
FDA ClearedK171227, K202172
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 2 FDA records

K171227 (Fotona D.O.O., 2017)

The Fotona StarWalker Laser System Family, and its accessories, are intended for: 1064 nm wavelength in Q-switched mode: • Removal of dark (black, blue, brown) tattoo ink • Treatment of nevus of ota • Treatment of common nevi • Removal and lightening of unwanted hair • Skin resurfacing procedures for the treatment of acne scars and wrinkles. 1064 nm wavelength in long pulse mode: • Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin • Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins • Coagulation and hemostasis of soft tissue • Treatment of wrinkles • Treatment of mild to moderate inflammatory acne vulgaris. 532 nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces): • Red, tan, purple and orange tattoo ink removal • Sky blue (light) tattoo ink removal […]

Excerpt — verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026; "[…]" marks text omitted from the source.

K202172 (Fotona D.O.O., 2020)

The StarWalker Laser System Family is indicated for: 1064 nm wavelength in Q-switched mode: • Removal of dark (black, blue, brown) tattoo ink • Treatment of nevus of ota • Treatment of common nevi • Removal and lightening of unwanted hair • Skin resurfacing procedures for the treatment of acne scars and wrinkles • Treatment of melasma • General dermatology indications: Incision, excision, ablation and vaporization of soft tissue. 1064 nm wavelength in long pulse mode: • Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin • Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins • Coagulation and hemostasis of soft tissue • Treatment of wrinkles • Treatment of mild to moderate inflammatory acne vulgaris. 532 nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces): • Red, tan, purple and orange tattoo ink removal • Sky blue (light) tattoo ink removal […]

Excerpt — verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026; "[…]" marks text omitted from the source.

Page updated: September 4, 2026 · How we verify

New and used price references
New$100k–$150k
Source not documented
Used$60k–$90k
Source not documented

Axis runs $0–$150k. 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: $100k–$150k·Researched estimate — no dated source on file yet; not a quote.
Used asking range: $60k–$90k·Researched estimate — no dated source on file yet; not a quote.
Key factsCompany, specifications and verification dates
Key facts
ManufacturerFotona
CompanyOwner: Vitruvian Partners LLP (London private equity); AGIC Capital retains a minority stake (private equity owned, since 2021) · Distribution: hybrid (direct + distributor)
Parent companyFotona
Brand ownerFotona
Built by (OEM)Fotona d.o.o.
CategoryPicosecond Tattoo/Pigment
TechnologyPico/nano adaptive QS Nd:YAG
FDA statusFDA Cleared
510(k) citationK171227, K202172
New price range$100k–$150k
Used asking range$60k–$90k
ConsumablesNot published
Launch year2020
PricingNot published
Manufacturer-source documents checkedNot published

Overview

MaQX pulse-stacking tattoo platform

FDA & regulatory detailClearance timeline, authorization route and citation notes
Authorized via 510(k)

510(k): K171227 (decision 18 Aug 2017) and K202172 (decision 19 Nov 2020). Checked 4 Sep 2026.

FDA-cleared indications (verbatim)

K171227 (Fotona D.O.O., 2017)

The Fotona StarWalker Laser System Family, and its accessories, are intended for: 1064 nm wavelength in Q-switched mode: • Removal of dark (black, blue, brown) tattoo ink • Treatment of nevus of ota • Treatment of common nevi • Removal and lightening of unwanted hair • Skin resurfacing procedures for the treatment of acne scars and wrinkles. 1064 nm wavelength in long pulse mode: • Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin • Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins • Coagulation and hemostasis of soft tissue • Treatment of wrinkles • Treatment of mild to moderate inflammatory acne vulgaris. 532 nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces): • Red, tan, purple and orange tattoo ink removal • Sky blue (light) tattoo ink removal […]

Excerpt — verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026; "[…]" marks text omitted from the source.

K202172 (Fotona D.O.O., 2020)

The StarWalker Laser System Family is indicated for: 1064 nm wavelength in Q-switched mode: • Removal of dark (black, blue, brown) tattoo ink • Treatment of nevus of ota • Treatment of common nevi • Removal and lightening of unwanted hair • Skin resurfacing procedures for the treatment of acne scars and wrinkles • Treatment of melasma • General dermatology indications: Incision, excision, ablation and vaporization of soft tissue. 1064 nm wavelength in long pulse mode: • Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin • Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins • Coagulation and hemostasis of soft tissue • Treatment of wrinkles • Treatment of mild to moderate inflammatory acne vulgaris. 532 nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces): • Red, tan, purple and orange tattoo ink removal • Sky blue (light) tattoo ink removal […]

Excerpt — verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026; "[…]" marks text omitted from the source.

Marketed for

Nd:YAG — Pico/nano adaptive QS Nd:YAG

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

Parent company: Fotona

Legal manufacturer: Fotona d.o.o. (Slovenia)

Applicant on the FDA record

Fotona d.o.o.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

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 Fotona StarWalker PQX 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.

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

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History6 tracked changes

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

  1. September 4, 2026

    FDA status

    UnknownCleared

    Clearance located on openFDA

    Source: Council round 2 audit, verified on openFDA 2026-09-04

  2. September 4, 2026

    FDA status

    UnknownCleared

    Source: Catalog update

  3. September 4, 2026

    510(k) numbers

    K-number set re-verified against openFDA

    Source: Council round 2 audit, verified on openFDA 2026-09-04

  4. September 4, 2026

    FDA K-numbers

    Source: Catalog update

  5. September 4, 2026

    FDA source URL

    Source: Catalog update

  6. August 1, 2026

    Record created

    Added to The Aesthetic Index — August 2026

    Source: The Aesthetic Index editorial

Cite this data: The Aesthetic Index, "Fotona StarWalker PQX — 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.