CE Marked medical device compliant with the requirements of the Medical Device Directive 93/42/EEC (MDD) as amended, as indicated in the LightSheer DUET regulatory documentation.
Class 4 laser per EN 60825 1 and Class IV laser per U.S. FDA CDRH classification.
LightSheer family covered by FDA 510(k) clearances for hair reduction and related aesthetic indications (e.g., LightSheer Pulsed Diode Array Laser Systems).
CE Marked medical device compliant with the requirements of the Medical Device Directive 93/42/EEC (MDD) as amended, as indicated in the LightSheer DUET regulatory documentation.
Class 4 laser per EN 60825 1 and Class IV laser per U.S. FDA CDRH classification.
LightSheer family covered by FDA 510(k) clearances for hair reduction and related aesthetic indications (e.g., LightSheer Pulsed Diode Array Laser Systems).
Manufactured under Lumenis quality management systems consistent with ISO 13485 for medical devices.
Description
The Lumenis LightSheer DUET is a high-powered 805 nm diode laser platform designed primarily for long-term hair reduction and the treatment of benign vascular and pigmented lesions. It combines two handpieces on one versatile workstation: the LightSheer ET with a 9 × 9 mm ChillTip contact-cooling sapphire tip for high-fluence, precise work on smaller areas, and the LightSheer HS with a 22 × 35 mm large spot size and integrated vacuum-assist technology for rapid treatment of large body areas such as backs and legs. The system delivers fluence up to approximately 100 J/cm² with pulse widths up to 400 ms, and is engineered to treat all Fitzpatrick skin types (I–VI) with minimal patient discomfort and reduced need for topical anaesthesia.
Bnefits
Two 805 nm diode hair removal technologies (ET and HS handpieces) on a single platform for both small and large treatment areas.
High-speed 22 × 35 mm HS handpiece with integrated vacuum-assist technology for faster, more comfortable treatment of large body areas.
ET handpiece with 9 × 9 mm ChillTip continuous contact cooling for precise, high-fluence treatment and enhanced epidermal protection.
No routine need for gels or topical anaesthetics, simplifying preparation and reducing treatment time.
Clinically established 805 nm diode wavelength suitable for all Fitzpatrick skin types (I–VI), including tanned skin, when used with appropriate settings.
Short treatment times and reduced prep time compared with earlier-generation diode lasers, improving clinic throughput and profitability.
Intuitive touchscreen interface with customizable presets and recommended treatment parameters to support consistent outcomes.
Part of the Lumenis LightSheer family, a widely used, well-documented technology with extensive clinical experience worldwide.
Indications
Permanent reduction of unwanted hair on the face and body in Fitzpatrick skin types I–VI, including tanned skin.
Treatment of benign pigmented lesions such as solar lentigines and other superficial epidermal benign pigmented lesions, where permitted by local regulatory clearances.
Treatment of benign vascular lesions, including small telangiectasias and leg or facial veins, within the device’s cleared indications.
Manufactured under Lumenis quality management systems consistent with ISO 13485 for medical devices.
Requires compliance with local laser safety regulations and standards (e.g., laser Controlled area setup, safety eyewear, signage and operator training) in the country of installation.
Requires compliance with local laser safety regulations and standards (e.g., laser Controlled area setup, safety eyewear, signage and operator training) in the country of installation.
Diode laser hair removal system
Treatment of pseudofolliculitis barbae (PFB) and reduction of ingrown hairs in appropriate candidates.
Use in surgical, aesthetic and cosmetic applications within general and plastic surgery and dermatology specialties, in line with the device’s regulatory clearances in the relevant country.
Composition
Energy source: high-power 805 nm diode laser modules.
Two handpieces: LightSheer ET (9 × 9 mm spot size with ChillTip sapphire contact cooling) and LightSheer HS (22 × 35 mm spot size with integrated vacuum-assist).
Maximum fluence: approximately 100 J/cm² (depending on handpiece and pulse width).
Pulse duration: variable, with minimum pulse lengths around 5 ms and pulse widths up to approximately 400 ms.
Laser classification: Class 4 laser per IEC/EN 60825-1 and Class IV laser per U.S. FDA CDRH.
Console with integrated touchscreen user interface, cooling, power supply, and system control electronics.
Footswitch for operator-controlled activation and system interlock circuits.
External accessories including protective eyewear, manuals and standard power cabling (exact configuration may vary by region and reseller).
Formulation
Floor-standing diode laser workstation with integrated touchscreen and dual-handpiece support.
LightSheer ET handpiece: 9 × 9 mm spot, ChillTip continuous contact cooling for high fluence and precise work on smaller areas (e.g., upper lip, chin, underarms, bikini line).
LightSheer HS handpiece: 22 × 35 mm spot with high-speed vacuum-assist technology to draw the skin into the handpiece, reduce competing chromophores and enable deeper, more efficient energy delivery with improved comfort.
Software with pre-programmed and customizable protocols based on skin type, hair colour, hair thickness and body area.
Closed-loop safety and monitoring systems including key switch, emergency stop, interlocks, and system diagnostics.
Designed for use in a standard clinical treatment room, with overall dimensions roughly 44 × 50 × 112 cm and weight around 48 kg (values may vary slightly by configuration).
Packaging
Capital equipment system typically supplied as a complete LightSheer DUET console with two handpieces (ET and HS), attached via system umbilicals.
Standard accessory kit typically includes footswitch, power cable, operator and patient protective eyewear, user/operator manual and basic maintenance tools (exact contents depend on region and reseller).
When sold via a broker such as Laser and Aesthetics on behalf of a customer, configuration may vary (e.g., number/condition of handpieces, included accessories); details are normally specified in the individual listing.
Shipped in manufacturer or reseller transport packaging suitable for large medical devices, with appropriate labelling and shock protection.
Usage
For professional use only; operators must complete manufacturer-approved training and comply with local laser safety regulations and clinic protocols.
Perform a full patient assessment including medical history, skin type, hair characteristics, medications, tanning status and contraindications before treatment.
Select the appropriate handpiece: ET for smaller or more delicate areas requiring higher fluence and precision; HS for large body areas requiring rapid coverage with vacuum assist.
Choose treatment parameters (fluence, pulse width, repetition, cooling) based on the device’s guidelines, patient skin type (Fitzpatrick I–VI), hair thickness and treatment area, starting conservatively and adjusting based on clinical response and test spots.
Ensure all personnel and the patient wear appropriate wavelength-specific laser protective eyewear; remove reflective objects from the treatment area.
Shave the treatment site if necessary; cleanse and dry the skin, removing makeup, lotions, deodorants or self-tanners.
Apply the handpiece perpendicular to the skin with appropriate contact (and vacuum engagement for HS) and deliver pulses in overlapping passes according to the protocol, monitoring skin response continuously.
Observe for immediate endpoints such as perifollicular erythema and oedema without excessive epidermal whitening or blistering; adjust settings if adverse reactions occur.
Provide post-treatment care instructions, including avoidance of sun exposure and use of broad-spectrum sunscreen, and guidance on managing transient erythema or oedema (e.g., cool packs, soothing topicals as appropriate).
Schedule and perform a series of treatment sessions, typically spaced several weeks apart, to coincide with hair growth cycles and optimise long-term reduction.
Follow all maintenance, calibration, and safety checks as outlined in the official operator manual, and arrange periodic servicing through an authorised Lumenis service provider or certified engineer.
Contraindications
Untreated or active skin infections, open wounds, inflammatory skin diseases or compromised skin integrity at the intended treatment site.
History of keloid scarring or abnormal wound healing in the proposed treatment area, unless carefully assessed and cleared by a specialist.
Photosensitive disorders or use of photosensitising medications that increase risk of adverse reactions at 805 nm.
Recent significant sun exposure, tanning (including artificial tanning) or use of self-tanning products on the treatment area, which may increase risk of burns or pigmentary changes.
Known hypersensitivity or severe adverse reaction to previous laser or light-based treatments at similar wavelengths.
Pregnancy and breastfeeding are commonly considered relative contraindications in aesthetic practice due to limited safety data, and treatments are often deferred.
Presence of active malignancy or suspicious pigmented lesions within the intended treatment zone.
Metal implants or medical devices in the treatment area that could interfere with safe energy delivery, depending on clinical judgement.
Patients with unrealistic expectations or conditions where hair reduction could mask underlying disease (e.g., certain endocrine disorders) without appropriate medical oversight.
Adverse Effects
Common, usually transient effects: erythema, perifollicular oedema, warmth, mild discomfort or a sunburn-like sensation at the treatment site.
Temporary pigmentary alterations such as post-inflammatory hyperpigmentation or hypopigmentation, particularly in darker or tanned skin or after excessive fluence.
Blistering, crusting or superficial burns if inappropriate parameters are used or cooling/contact is inadequate.
Rare risk of scarring or textural changes in cases of significant thermal injury.
Paradoxical hair growth in rare cases, particularly in areas with fine vellus hair and hormonal influences.
Ocular injury if proper eye protection is not used; strict adherence to eye safety protocols is essential.
Allergic or irritant reactions to pre- or post-care topicals rather than the laser itself.
Storage Conditions
Install and operate the system in a clean, dry clinical environment with stable mains power and adequate ventilation.
Operate and store within the temperature and humidity ranges specified in the operator manual (typically standard indoor clinical ranges; avoid extremes of heat, cold and humidity).
Protect the laser and handpieces from shock, vibration and dust; use original or equivalent protective covers when the system is not in use.
Do not expose the system to direct sunlight or sources of heat that exceed the specified environmental limits.
Ensure all cooling vents are unobstructed and that the system is placed on a stable, level surface.
Disconnect from mains power and follow manufacturer instructions if the device is transported or stored for extended periods.
Duration
Hair reduction typically requires a series of sessions (often around 4\u20138 treatments or more, spaced approximately 4\u20138 weeks apart depending on body area and hair growth cycle), with long-term reduction outcomes maintained with occasional top-up sessions as needed. Individual session times can be as short as around 15 minutes for large areas such as backs or legs when using the HS handpiece.
Onset
Initial effects, such as reduced hair growth and shedding of treated hairs, are usually observed within several days to a few weeks after each session. Progressive long-term hair reduction develops over the full course of multiple treatments aligned with the hair growth cycle.
