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Acclaro Medical UltraClear

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Novel Ablative Fiber · 2910nm cold-ablative fiber laser (3DMIRACL)

Classification & configurations

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

Current

At a glance

New price
Not published
FDA status
Supplies & recurring costs
Acclaro's store lists 10 Quick Change Tips for $490, excluding treatment credits (checked September 18, 2026). That is $49 per tip, not a verified total cost per treatment.
View supply details
Sources and verified data on file

Data on file

Recurring consumables
Not verified
FDA
FDA ClearedK233803
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.

Manufacturer-source documents checked: August 31, 2026

·FDA database · Updated Sep 18, 2026
Read FDA-cleared indicationsExact wording from 1 FDA record

K233803 (Acclaro Corporation, 2024)

The UltraClear Fractional Laser System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytids, furrows, fine lines, textural irregularities, epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), benign pigmented lesions, and vascular dyschromia. Fractional Effects: The UltraClear Fractional Laser System with its accessories when used in Ultra mode is intended to produce fractional effects during skin resurfacing.

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

Page updated: September 22, 2026 · How we verify

No new-equipment price range is published for this model. Ask the seller for a dated, itemized quote covering configuration, training and service.

Price sourcesSources, dates and configurations
New: Not published·Dealer quote · Updated Aug 12, 2026Prior unverified catalog range: $150,000–$200,000; old prose stated up to $225,000. One legacy dealer-quote observation, no linked source document or itemized package. Current price withheld pending evidence; neither endpoint is an established attainable price.
Key factsCompany, specifications and verification dates
Key facts
ManufacturerAcclaro Medical
CompanyNot published
Parent companyAcclaro Medical
Brand ownerAcclaro Medical
Built by (OEM)Acclaro Medical Inc.
CategoryNovel Ablative Fiber
Technology2910nm cold-ablative fiber laser (3DMIRACL)
FDA statusFDA Cleared
510(k) citationK233803
New price rangeNot published
Used asking rangeNot published
ConsumablesAcclaro's store lists 10 Quick Change Tips for $490, excluding treatment credits (checked September 18, 2026). That is $49 per tip, not a verified total cost per treatment.
Launch year2022
PricingNot published
Manufacturer-source documents checkedAugust 31, 2026

Overview

UltraClear is Acclaro's 2910 nm fractional laser platform. Compare the exact treatment mode, current manufacturer labeling and itemized supply costs before purchasing.

How it worksTechnology and manufacturing

How the technology works

A published study enrolled 20 subjects with facial photoaging for two superficial-mode treatments. Blinded photographs at three months showed improvement in overall photoaging.

This small study did not compare UltraClear with Fraxel or CO2 and does not establish outcomes for every pigmentation disorder or skin type. Source: Bernstein et al., Lasers in Surgery and Medicine (2023), PMID 36465001.

Origin

United States (Acclaro Medical, founded 2018; US operations/engineering with global corporate HQ relocated to Munich, Germany in late 2024).

FDA & regulatory detailClearance timeline, authorization route and citation notes

Source and verification notes

·FDA database · Updated Sep 18, 2026K233803 UltraClear Fractional Laser System; FDA decision letter dated May 8, 2024. Scope checked against the Indications for Use and 510(k) summary; this is not a complete operator-manual safety review.
Authorized via 510(k)

K233803 identifies the UltraClear Fractional Laser System and lists dermatological coagulation, resurfacing and soft-tissue ablation, including benign pigmented lesions and vascular dyschromia. Ultra mode is intended to produce fractional effects during resurfacing. This clearance is not evidence of superiority to another laser or a guarantee for every pigmentation condition.

FDA-cleared indications (verbatim)

K233803 (Acclaro Corporation, 2024)

The UltraClear Fractional Laser System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytids, furrows, fine lines, textural irregularities, epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), benign pigmented lesions, and vascular dyschromia. Fractional Effects: The UltraClear Fractional Laser System with its accessories when used in Ultra mode is intended to produce fractional effects during skin resurfacing.

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

Marketed for

Novel Ablative Fiber — 2910nm cold-ablative fiber laser (3DMIRACL)

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

Parent company: Acclaro Medical

Legal manufacturer: Acclaro Medical Inc. (United States)

Applicant on the FDA record

Acclaro CorporationThe 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

The Acclaro UltraClear eStore lists a 10-tip pack at $490 and explicitly excludes treatment credits. Dividing the pack price gives $49 per tip; it does not establish how many tips or credits your intended protocol requires.

Obtain a dated quote for tips, treatment credits, smoke-evacuation supplies, shipping and taxes. We have not verified the complete per-treatment cost.

·Manufacturer-provided · Updated Sep 18, 2026
Source notes

Manufacturer store lists $490 for 10 tips, excluding treatment credits. $49 is arithmetic per tip, not a verified total per-treatment cost. Complete protocol and credit pricing remain unverified.

Additional supply notes

Acclaro's store lists 10 Quick Change Tips for $490, excluding treatment credits (checked September 18, 2026). That is $49 per tip, not a verified total cost per treatment.

Annual service & support

No annual service cost documented yet.

ComplianceScreening and contraindications on the manufacturer's record

Contraindications & screening

A complete, current manufacturer contraindication and screening checklist has not been verified in our records. Obtain the current operator manual and have a qualified clinician assess patient selection and risks.

The earlier claim of broad suitability for darker skin compared with CO2 was not established by the evidence cited here.

Warranty & serviceWhat to confirm in writing before you buy

Published warranty details

Acclaro advertises:

- A 24-hour response to service calls.

- Clinical training and provider-portal access.

A response time is not a repair-time guarantee. Ask for the written warranty, annual service price, exclusions and loaner terms.

·Manufacturer-provided · Updated Sep 21, 2026
Source notes

Acclaro support page reviewed September 21, 2026: advertises a 24-hour service-call response, clinical training and provider-portal access. These are manufacturer-stated support features, not independently measured service performance.

The reviewed page does not establish the prior one-year warranty or $12,000–$18,000 annual service range. Obtain contractual coverage and pricing in writing.

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

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Current alternatives

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

No current alternatives identified in the catalog yet. Browse current models

History16 tracked changes

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

  1. September 22, 2026

    Warranty & service

    Source: Catalog update

  2. September 21, 2026

    Ownership economics evidence correction

    Removed unsupported treatment-price/volume, resale/value-retention and best-fit economic assertions. Replaced warranty/service prose with attributed manufacturer support features and a request for written terms. No new economic observation or blanket verification. Prior prose and treatment provenance preserved in this entry.

    Source: https://ultraclearlaser.com/about/success/

  3. September 18, 2026

    FDA source URL

    https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233803.pdf

    Source: Catalog update

  4. September 18, 2026

    notes

    September 18 source audit: narrowed claims to identified evidence, distinguished pack price from treatment cost, and retained prior wording for the correction history.

    Source: https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233803.pdf

  5. September 18, 2026

    science

    September 18 source audit: narrowed claims to identified evidence, distinguished pack price from treatment cost, and retained prior wording for the correction history.

    Source: https://pubmed.ncbi.nlm.nih.gov/36465001/

  6. September 18, 2026

    patented tech

    September 18 source audit: narrowed claims to identified evidence, distinguished pack price from treatment cost, and retained prior wording for the correction history.

    Source: https://pubmed.ncbi.nlm.nih.gov/36465001/

  7. September 18, 2026

    contraindications

    September 18 source audit: narrowed claims to identified evidence, distinguished pack price from treatment cost, and retained prior wording for the correction history.

    Source: https://pubmed.ncbi.nlm.nih.gov/36465001/

  8. September 18, 2026

    consumables

    September 18 source audit: narrowed claims to identified evidence, distinguished pack price from treatment cost, and retained prior wording for the correction history.

    Source: https://shop.acclaromd.com/ultraclear-estore

  9. September 18, 2026

    consumables detail

    September 18 source audit: narrowed claims to identified evidence, distinguished pack price from treatment cost, and retained prior wording for the correction history.

    Source: https://shop.acclaromd.com/ultraclear-estore

  10. September 18, 2026

    fda scope note

    September 18 source audit: narrowed claims to identified evidence, distinguished pack price from treatment cost, and retained prior wording for the correction history.

    Source: https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233803.pdf

  11. September 18, 2026

    fda search completed on

    2026-09-082026-09-18

    September 18 source audit: narrowed claims to identified evidence, distinguished pack price from treatment cost, and retained prior wording for the correction history.

    Source: https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233803.pdf

  12. September 18, 2026

    New price range

    150000-200000Not verified — current price withheld

    The prior equipment price band had one legacy dealer-quote entry but no linked source document, and its upper limit conflicted with the description. Withheld the current price band pending itemized evidence; preserved prior values here. The revised overview reflects a published pilot study without promising economic returns or safety across all skin types.

    Source: https://onlinelibrary.wiley.com/doi/10.1002/lsm.23714

  13. September 18, 2026

    New price range

    150000-200000

    Source: Catalog update

  14. September 7, 2026

    patented tech

    Source: Catalog update — editorial sentences removed (neutral-voice standard, 7 Sep 2026)

  15. August 5, 2026

    Warranty & service

    Source: Catalog update

  16. August 1, 2026

    Record created

    Added to The Aesthetic Index — August 2026

    Source: The Aesthetic Index editorial

Cite this data: The Aesthetic Index, "Acclaro Medical UltraClear — 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.