Lumenis OptiLIGHT
IPL platform · Optimal Pulse Technology IPL
Technology: IPL
Classification & configurations
Category group: Hair removal (diode, alexandrite, Nd:YAG, IPL)
At a glance
- New price
- Not published
- FDA status
Record scope: De Novo: DEN200028 (Lumenis Stellar M22 — intense pulsed light for dry eye disease due to meibomian gland dysfunction, granted 23 Feb 2021); FDA's device listing carries OptiLight under DEN200028 (product code QIU). Platform 510(k): K193500 (Stellar M22, 16 Jan 2020). Checked 8 Sep 2026.
- Supplies & recurring costs
- Supply details not yet documented.
Sources and data on file
Data on file
- Recurring consumables
- Not verified
- FDA
- FDA record cited — see scopeDe Novo: DEN200028, K193500
- 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
Universal IPL with a spectrum of 400-1200nm (with different filters) is indicated for: Improvement of signs of Dry Eye Disease (DED) due to Meibomian Gland Dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, in patients 22 years of age and older with moderate to severe signs and symptoms of DED due to MGD and with Fitzpatrick skin types I-IV. IPL is to be applied only to skin on the malar region of the face, from tragus to tragus including the nose (eyes should be fully covered by protective eyewear). IPL is intended to be applied as an adjunct to other modalities, such as meibomian gland expression, artificial tear lubricants and warm compresses.
Verbatim from the FDA De Novo decision summary, retrieved 8 Sep 2026.
K193500 (Lumenis, Ltd., 2020)
The subject Stellar M22 has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows: The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for: o Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles) o Cutaneous lesions, including warts, scars and striae o Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations o Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles o Mild to moderate inflammatory Acne (Acne vulgaris) The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is indicated for: o The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg o The removal of unwanted hair and to effect table long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles o The non-ablative treatment of facial wrinkles ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for: o Use in dermatological procedures requiring fractional skin resurfacing and0684 coagulation of soft tissue The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for: o Removal of dark tattoos o Treatment of pigmented lesions *Note Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: October 6, 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 | 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 | IPL platform |
| Technology | Optimal Pulse Technology IPL |
| FDA status | FDA record cited — see scope |
| De Novo citation | De Novo: DEN200028, K193500 |
| 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
OptiLIGHT is Lumenis’s IPL system for management of dry eye disease due to meibomian gland dysfunction. It uses Optimal Pulse Technology.
This is an eye-care application; consult the specific labeling rather than assuming general aesthetic IPL indications.
FDA & regulatory detailClearance timeline, authorization route and citation notes
De Novo: DEN200028 (Lumenis Stellar M22 — intense pulsed light for dry eye disease due to meibomian gland dysfunction, granted 23 Feb 2021); FDA's device listing carries OptiLight under DEN200028 (product code QIU). Platform 510(k): K193500 (Stellar M22, 16 Jan 2020). Checked 8 Sep 2026.
FDA-cleared indications (verbatim)
Universal IPL with a spectrum of 400-1200nm (with different filters) is indicated for: Improvement of signs of Dry Eye Disease (DED) due to Meibomian Gland Dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, in patients 22 years of age and older with moderate to severe signs and symptoms of DED due to MGD and with Fitzpatrick skin types I-IV. IPL is to be applied only to skin on the malar region of the face, from tragus to tragus including the nose (eyes should be fully covered by protective eyewear). IPL is intended to be applied as an adjunct to other modalities, such as meibomian gland expression, artificial tear lubricants and warm compresses.
Verbatim from the FDA De Novo decision summary, retrieved 8 Sep 2026.
K193500 (Lumenis, Ltd., 2020)
The subject Stellar M22 has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows: The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for: o Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles) o Cutaneous lesions, including warts, scars and striae o Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations o Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles o Mild to moderate inflammatory Acne (Acne vulgaris) The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is indicated for: o The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg o The removal of unwanted hair and to effect table long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles o The non-ablative treatment of facial wrinkles ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for: o Use in dermatological procedures requiring fractional skin resurfacing and0684 coagulation of soft tissue The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for: o Removal of dark tattoos o Treatment of pigmented lesions *Note Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
IPL — Optimal Pulse Technology IPL
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
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
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
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Enter your quote and treatment costs for Lumenis OptiLIGHT. Published figures appear where available; review them before using the estimate.
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Warranty & serviceWhat to confirm in writing before you buy
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History5 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
October 6, 2026
Source-based profile correction
{"product_url": null} → {"product_url": "https://lumenis.com/vision/products/optilight/"}
Official-source review on October 6, 2026 of the listed fields only. Pricing, regulatory records and current sales availability are not independently verified by this edit.
Source: https://lumenis.com/vision/products/optilight/
October 1, 2026
Profile accuracy audit
Replaced stale catalog-candidate wording with the manufacturer-described purpose. Existing De Novo citation and scope preserved.
Source: https://lumenis.com/vision/products/optilight/
September 8, 2026
FDA status
Unknown → Cleared
Source: Record correction
September 8, 2026
FDA K-numbers
DEN200028; K193500
Source: Record correction
September 8, 2026
FDA source URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN200028
Source: Record correction
Cite this data: The Aesthetic Index, "Lumenis OptiLIGHT — pricing, FDA status and cost to own", aestheticindex.co (accessed November 3, 2026).
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