Iridex DioLite XP
KTP/532 & Nd:YAG Vascular · 532nm KTP diode-pumped
Technology: Diode Laser
Classification & configurations
Category group: Resurfacing & pigment (ablative, fractional, picosecond, vascular)
At a glance
- New-unit reference · older model
- Not published
- Used asking price
- $4k–$10kSource 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
- FDA ClearedK964074
- 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
K964074 (Iriderm Div., 1997)
The DioLite 532 is a semiconductor-based laser system which delivers 532 nm laser light intended to be used for the photocoagulation of vascular and pigmented skin lesions.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: September 8, 2026 · How we verify
No new-unit price reference is published for this older model.
Axis runs $0–$10k. 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 | Iridex |
|---|---|
| Company | Not published |
| Parent company | Iridex |
| Brand owner | Iridex |
| Built by (OEM) | Iridex Corporation |
| Category | KTP/532 & Nd:YAG Vascular |
| Technology | 532nm KTP diode-pumped |
| FDA status | FDA Cleared |
| 510(k) citation | K964074 |
| New-unit reference (older model) | Not published |
| Used asking range | $4k–$10k |
| Consumables | Not published |
| Launch year | 2005 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Desktop KTP for telangiectasia/lentigines
FDA & regulatory detailClearance timeline, authorization route and citation notes
Launch 2005 · Clearance 2026 · K964074
Family clearance: K964074 (DioLite 532, Iriderm/Iridex, decision 1 Apr 1997); no 510(k) naming DioLite XP was located. Checked 8 Sep 2026.
FDA-cleared indications (verbatim)
K964074 (Iriderm Div., 1997)
The DioLite 532 is a semiconductor-based laser system which delivers 532 nm laser light intended to be used for the photocoagulation of vascular and pigmented skin lesions.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
Diode laser — 532nm KTP diode-pumped
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: Iridex
Legal manufacturer: Iridex Corporation (United States)
Applicant on the FDA record
Iridex Corp. (Iriderm Div.)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 Iridex DioLite XP 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
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Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
History8 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 8, 2026
FDA source URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K964074
Source: Record correction
September 8, 2026
FDA status
Unknown → Cleared
Source: Record correction
September 8, 2026
FDA K-numbers
K964074
Source: Record correction
September 4, 2026
FDA status
Source: Catalog update
September 4, 2026
FDA indication
Catalog update — FDA record rechecked.
Source: Catalog update
September 4, 2026
FDA status
No US 510(k) naming this model located; cleared assertion removed
Source: Council round 2 audit, verified on openFDA 2026-09-04
August 9, 2026
FDA status
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, "Iridex DioLite XP — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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