Accure
Acne laser (1726nm sebaceous) · 1726nm selective sebaceous laser
Classification & configurations
Category group: Resurfacing & pigment (ablative, fractional, picosecond, vascular)
At a glance
- New price
- Not published
- FDA status
Record scope: 510(k): K222109 (decision 17 Nov 2022) and K242035 (decision 11 Oct 2024). Checked 4 Sep 2026.
- Supplies & recurring costs
- Supply details not yet documented.
Sources and 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.
Read FDA-cleared indicationsExact wording from 2 FDA records
K222109 (Accure Acne, Inc., 2022)
The Accure Laser System is indicated for the treatment of mild to severe inflammatory acne vulgaris. .
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K242035 (Accure Acne, Inc., 2024)
The Accure Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgaris.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: October 1, 2026 · How we verify
New-equipment price not yet documented
For a complete budget, ask for an itemized quote covering the device, accessories, training and service.
Price sourcesSources, dates and configurations
No price sources are documented yet. Ask the seller for a current, itemized quote.
Key factsCompany, specifications and verification dates
| Manufacturer | Accure Acne |
|---|---|
| Company | Not published |
| Parent company | Accure Acne |
| Brand owner | Accure Acne |
| Built by (OEM) | Accure Acne Inc. |
| Category | Acne laser (1726nm sebaceous) |
| Technology | 1726nm selective sebaceous laser |
| FDA status | FDA record cited — see scope |
| 510(k) citation | K222109, K242035 |
| New price range | Not published |
| Used price reference | Not published |
| Consumables | Not published |
| Launch year | Not published |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
The Accure Acne Laser System uses a 1726 nm laser, temperature-based control and forced-air cooling. FDA records K222109 and K242035 identify the Accure Laser System.
Refer to the applicable labeling for treatment indications and patient selection.
FDA & regulatory detailClearance timeline, authorization route and citation notes
510(k): K222109 (decision 17 Nov 2022) and K242035 (decision 11 Oct 2024). Checked 4 Sep 2026.
FDA-cleared indications (verbatim)
K222109 (Accure Acne, Inc., 2022)
The Accure Laser System is indicated for the treatment of mild to severe inflammatory acne vulgaris. .
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K242035 (Accure Acne, Inc., 2024)
The Accure Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgaris.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
Acne laser (1726nm sebaceous) — 1726nm selective sebaceous laser
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: Accure Acne
Legal manufacturer: Accure Acne Inc. (United States)
Applicant on the FDA record
Accure Acne, 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.
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.
- RecallZ-0778-2024Class IIOngoing
Initiated Dec 6, 2023 · 22
Scope as FDA lists it
Accure Laser System, Model: PFMS00004 Affected codes: UDI-DI: 08059173392230, Serial Numbers: LAD0000-0004, LAD0000-0014, PROT01-0720, LAD0000-0012, LAD0000-0005, LAD2216-0623, LAD2356-0723, LAD0000-0003, PROTO07-1120, LAD2076-0623, LAD0000-0011, LAD0000-0008, LAD0000-0010, LAD2357-0723, LAD2075-0623, LAD2232-0723, LAD0000-0013, LAD0000-0009, LAD0000-0006, LAD0000-0001, PROT06-1120, LAD2507-0723 Distribution: US distribution to states of: CO, CA, CT, NY, NJ, MN, LA, OH, MA, TX
Reason and action
Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, which may cause blistering.
Recalling firm as FDA lists it: Accure Acne, Inc.
Check the FDA record for affected models, lots or serial numbers and the required action.
Manufacturer response: none on file — manufacturers can reply via their company profile.
FDA record
Treatment & running costs
Treatment and running-cost details aren’t documented yet.
Ask the supplier for the session schedule, supplies per treatment and annual service costs.
Use your own figures in the calculatorPayback calculatorEnter your quote, volume and running costs
Estimate your payback
Enter your quote and treatment costs for Accure. Published figures appear where available; review them before using the estimate.
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.
New price not published — enter the number on your quote.
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.
Required — include staff time and your own time. Enter 0 only to explicitly exclude labor from this estimate.
Annual service contract ÷ 12, if you carry one.
Your estimate
Enter purchase price, price you charge per treatment, consumable cost per treatment, labor 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
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Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
History6 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
October 1, 2026
Profile accuracy audit
Replaced stale catalog-candidate wording with a manufacturer-sourced technology description. FDA identity verified at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242035 .
Source: https://accureacne.com/the-accure-acne-laser-system/
September 4, 2026
FDA status
Unknown → Cleared
Clearance located on openFDA
Source: Council round 2 audit, verified on openFDA 2026-09-04
September 4, 2026
FDA status
Unknown → Cleared
Source: Catalog update
September 4, 2026
510(k) numbers
K-number set re-verified against openFDA
Source: Council round 2 audit, verified on openFDA 2026-09-04
September 4, 2026
FDA K-numbers
Source: Catalog update
September 4, 2026
FDA source URL
Source: Catalog update
Cite this data: The Aesthetic Index, "Accure — pricing, FDA status and cost to own", aestheticindex.co (accessed November 3, 2026).
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