Lumenis One
Multi-app platform · Universal IPL + 1064 + LightSheer diode
Technology: Diode Laser
Classification & configurations
Category group: Hair removal (diode, alexandrite, Nd:YAG, IPL)
At a glance
- New-unit reference · older model
- Not published
- Used asking price
- $8k–$18kSource 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 ClearedK030342
- 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
K030342 (Lumenis, Ltd., 2003)
The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems (and the delivery accessories that are used with them to deliver light and/or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. Intense Pulsed Light Energy/ Wavelengths (515 - 1200 nm) are indicated for: * The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars and striae; LUMENIS, fNC. MODIFICATIONTO IPL AND I P W D : Y A G COMB~NAT~ONPRODUCTFAMIUES CONFlDENTIAL 6 2 V. VI. * The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent2, hair reduction in skin types I-V through selective targeting o f melanin in hair follicles. * Nd:YAG Laser Wavelength (1064 nm) is indicated for the coagulation and hemostasis of vascular lesions and soft tissue, including: * Treatment and clearance of superficial and deep telangectasias (venulectasias)and reticular veins (0.1 - 4.0 mm diameter) of the leg. The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent2, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: August 6, 2026 · How we verify
No new-unit price reference is published for this older model.
Axis runs $0–$18k. 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 | Lumenis |
|---|---|
| Company | Owner: Baring Private Equity Asia (BPEA, now part of EQT) (private equity owned, since 2019) · Distribution: direct |
| Parent company | Lumenis |
| Brand owner | Lumenis |
| Built by (OEM) | Lumenis Be Ltd. |
| Category | Multi-app platform |
| Technology | Universal IPL + 1064 + LightSheer diode |
| FDA status | FDA Cleared |
| 510(k) citation | K030342 |
| New-unit reference (older model) | Not published |
| Used asking range | $8k–$18k |
| Consumables | Not published |
| Launch year | 2003 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Predecessor to M22 concept
FDA & regulatory detailClearance timeline, authorization route and citation notes
FDA-cleared indications (verbatim)
K030342 (Lumenis, Ltd., 2003)
The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems (and the delivery accessories that are used with them to deliver light and/or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. Intense Pulsed Light Energy/ Wavelengths (515 - 1200 nm) are indicated for: * The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars and striae; LUMENIS, fNC. MODIFICATIONTO IPL AND I P W D : Y A G COMB~NAT~ONPRODUCTFAMIUES CONFlDENTIAL 6 2 V. VI. * The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent2, hair reduction in skin types I-V through selective targeting o f melanin in hair follicles. * Nd:YAG Laser Wavelength (1064 nm) is indicated for the coagulation and hemostasis of vascular lesions and soft tissue, including: * Treatment and clearance of superficial and deep telangectasias (venulectasias)and reticular veins (0.1 - 4.0 mm diameter) of the leg. The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent2, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
Diode laser — Universal IPL + 1064 + LightSheer diode
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
510(k) numbers
Parent company: Lumenis
Legal manufacturer: Lumenis Be Ltd. (Israel)
Applicant on the FDA record
Lumenis, Ltd.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 Lumenis One 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.
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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.
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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.
History4 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
August 5, 2026
FDA status
Unknown → Cleared
Source: Catalog update
August 5, 2026
FDA indication
Multi-application IPL + Nd:YAG + diode platform (family)
Source: Catalog update
August 5, 2026
FDA K-numbers
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, "Lumenis One — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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