Fotona Dualis 1064 nm Nd:YAG KTP Laser System
Fotona Dualis
Medical deviceDual-wavelength aesthetic and surgical laser platform (Nd:YAG/KTP)
Certifications
- Fotona medical laser systems are CE marked for sale in the European Union in accordance with applicable medical device directives and regulations.
- Manufactured under certified quality management systems including ISO 9001 and EN ISO 13485 for medical devices.
- Conforms to relevant electrical safety and performance standards for medical electrical equipment (e.g. IEC/EN 60601 series) and applicable laser safety standards.
- Subject to national approvals or clearances (such as FDA 510(k) for specific Dualis laser variants and indications) in markets where additional regulatory authorisation is required.
- Fotona medical laser systems are CE marked for sale in the European Union in accordance with applicable medical device directives and regulations.
- Manufactured under certified quality management systems including ISO 9001 and EN ISO 13485 for medical devices.
- Conforms to relevant electrical safety and performance standards for medical electrical equipment (e.g. IEC/EN 60601 series) and applicable laser safety standards.
- Subject to national approvals or clearances (such as FDA 510(k) for specific Dualis laser variants and indications) in markets where additional regulatory authorisation is required.
Dual-wavelength aesthetic and surgical laser platform (Nd:YAG/KTP)
Description
The Fotona Dualis 1064 nm Nd:YAG / KTP laser system is a high-performance, dual-wavelength medical laser platform designed for aesthetic dermatology and a variety of surgical soft-tissue applications. Based on a flashlamp-pumped solid-state Nd:YAG laser source at 1064 nm with a frequency-doubled KTP module at 532 nm, the system delivers long-pulse, millisecond-range energy for deep heating of vascular and pigmented targets while preserving the epidermis. In aesthetic practice it is used for hair removal on all skin types, vascular and pigmented lesion treatments, photorejuvenation and onychomycosis protocols, while in surgery the KTP wavelength is indicated for incision, ablation, vaporisation, coagulation and haemostasis of soft tissue and vascular lesions. Many Dualis platforms are configured in the Dualis SP family, combining Nd:YAG with complementary Er:YAG capability for resurfacing and scar revision, providing a broad range of treatments from gentle, non-ablative rejuvenation to ablative skin resurfacing. In the specific context provided, the 1064 nm Nd:YAG arm is described as fully functional, while the KTP 532 nm module is no longer operational and would require service before clinical use.
Bnefits
- Dual-wavelength configuration (1064 nm Nd:YAG and 532 nm KTP) allows treatment of deep and superficial vascular and pigmented targets with one platform.
- Long-pulse 1064 nm Nd:YAG penetrates deeply with low epidermal absorption, enabling effective hair removal and vascular treatments on all skin types, including darker phototypes.
- KTP 532 nm wavelength provides strong absorption in oxyhaemoglobin and melanin, ideal for superficial vascular lesions, erythema and some pigmented lesions.
- Homogeneous beam profile and scanner compatibility (in Dualis SP/XP configurations) support fast coverage of large areas and consistent fluence delivery.
- Variable Square Pulse (VSP) and long-pulse technology allow tailoring of pulse duration and energy to indication and skin type, optimising efficacy while reducing downtime.
- Er:YAG compatibility in Dualis SP configurations enables fractional or full-field ablative resurfacing, scar revision and precise cold ablation of superficial lesions.
- CE-marked medical laser system manufactured under ISO 9001 and ISO 13485 quality management and EU medical device directives.
- Proven clinical utility in hair reduction, vascular treatments, photoaging, scars and onychomycosis in published clinical studies and long-term clinical use.
Indications
- Aesthetic dermatology: long-pulse Nd:YAG treatments for permanent hair reduction on all skin types, treatment of telangiectasia, spider veins, leg veins and other vascular lesions, photorejuvenation and improvement of diffuse redness and rosacea.
- Dermatology and surgery (KTP 532 nm): incision, ablation, vaporisation, coagulation and haemostasis of vascular lesions and soft tissue including skin, cutaneous and subcutaneous tissue, muscle, mucous membrane, lymphatic tissue, organs and glands; treatment and blanching of angiomas, haemangiomas and telangiectasias.
- Skin resurfacing and scar revision (on Dualis SP Er:YAG configurations): ablative and fractional resurfacing for acne scars, peri-oral and peri-orbital wrinkles, keloids and hypertrophic scars as per clinical protocols.
- Onychomycosis: long-pulse 1064 nm Nd:YAG treatments of fingernail and toenail fungal infections using millisecond pulses and spiral scanning patterns in accordance with validated protocols.
- General and plastic surgery (KTP, where cleared): soft-tissue incision/excision, tissue ablation and vessel coagulation in dermatologic, ENT, oral/maxillofacial, gynaecologic and general surgical applications, as per local regulatory clearances.
Composition
- Laser sources: flashlamp-pumped solid-state Nd:YAG laser (1064 nm) and frequency-doubled Nd:YAG KTP laser (532 nm) housed in a single console; certain Dualis SP variants also include an Er:YAG laser (2940 nm).
- Optical cavities: separate cavities containing Nd:YAG and KTP (and, in some models, Er:YAG) crystals with shared power supply, cooling and control systems.
- Beam delivery: Nd:YAG via optical fibre delivery to scanning and non-scanning handpieces; KTP via fibre delivery to focusing handpieces; Er:YAG (where present) via articulated arm to dedicated handpieces.
- Integrated aiming beam: visible red diode aiming beam combined coaxially with the therapeutic beam by a beamsplitter assembly for accurate targeting.
- User interface and controls: system computer with control panel or touch-screen interface for wavelength selection, fluence, pulse duration, repetition rate and scanner parameters; safety interlocks and key switch.
- Ancillary components: optional MedArt or similar scanner for hair removal and large-area treatments, footswitch for laser activation, cooling interfaces and safety eyewear appropriate to each wavelength.
Formulation
- Laser type: long-pulse Nd:YAG (1064 nm) with frequency-doubled KTP (532 nm) module; some Dualis SP configurations add Er:YAG (2940 nm) for ablative resurfacing.
- Nd:YAG specifications (typical Dualis SP family): wavelength 1064 nm; pulse fluence up to approximately 400 J/cm²; pulsewidth range about 5–200 ms; maximum power around 25 W; spot sizes typically 2–8 mm; scanner area around 22.7 cm².
- KTP specifications (typical Dualis KTP systems): wavelength 532 nm; long-pulse and/or Q-switched operation depending on configuration; intended for superficial vascular and pigmented lesions with fibre-delivered handpieces.
- Beam delivery type: optical fibre for Nd:YAG and KTP wavelengths; 7-mirror articulated arm for Er:YAG (where present).
- Control technologies: Variable Square Pulse (VSP) technology for customising pulse shape; Energy Feedback Control (EFC) for real-time monitoring and matching of delivered energy to set parameters.
- Device classification: powered laser surgical instrument (e.g. FDA product code GEX) and CE-marked medical laser for aesthetic, dermatologic and surgical indications, depending on exact Dualis variant and regulatory jurisdiction.
Packaging
- Primary system supplied as a floor-standing laser console containing Nd:YAG and KTP laser cavities, power supply, cooling system and user interface.
- Standard accessory set typically includes one or more Nd:YAG handpieces (with or without scanner), KTP fibre handpieces, footswitch, key, protective covers and basic maintenance tools.
- System may be shipped on a pallet in a protective crate with internal foam or bracing, with documentation pack (operator’s manual, installation and service information, safety labels and compliance certificates).
- In the used-equipment context, packaging and included accessories may vary and should be verified with the seller (e.g. whether KTP module, fibre, scanner and footswitch are included and functional).
Usage
- Only trained and appropriately credentialed medical professionals should operate the Fotona Dualis laser system after completing manufacturer-approved training and thoroughly reviewing the official operator manual.
- Before use, ensure the system has been installed, calibrated and safety-checked by qualified service personnel, including verification of emergency stop, interlocks, footswitch and beam alignment.
- Select the appropriate wavelength (1064 nm Nd:YAG or 532 nm KTP) and treatment parameters (fluence, pulse duration, spot size and repetition rate) according to the indication, skin type and protocol, using manufacturer treatment guidelines and current clinical evidence.
- Verify that all persons in the treatment room, including the patient and staff, are wearing wavelength-appropriate laser safety eyewear and that warning signage is in place.
- Prepare the treatment area according to the indication (e.g. shave hair, cleanse skin, remove make-up, debride nail surface for onychomycosis), and perform a test spot where appropriate to assess tissue response.
- Use appropriate skin cooling measures where indicated (contact cooling, cryo-cooling or air cooling) to improve patient comfort and minimise epidermal injury during long-pulse Nd:YAG or KTP treatments.
- Hold the handpiece perpendicular to the skin or nail surface and move systematically following the recommended overlap and scanning pattern, avoiding excessive stacking of pulses on the same site.
- Continuously monitor tissue response and patient feedback; adjust parameters as needed within safe ranges and discontinue treatment if excessive whitening, blistering, unexpected bleeding or severe pain occurs.
- After treatment, apply appropriate post-procedure care (e.g. cooling, topical emollients, sun avoidance and sunscreen) and provide written aftercare instructions and follow-up schedule to the patient.
- In the context described, do not attempt to use the non-functional KTP module clinically until it has been inspected, repaired and validated by an authorised Fotona service engineer; operate only the Nd:YAG arm that has been confirmed fully functional.
Contraindications
- Known hypersensitivity or contraindication to light/laser therapy, including certain photosensitive dermatoses or concurrent use of strongly photosensitising medications, unless cleared by a specialist.
- Active infection, open wounds, severe dermatitis or uncontrolled inflammatory skin disease in the intended treatment area.
- Suspicious pigmented lesions or skin cancers in the treatment zone that have not been evaluated and cleared for laser treatment by a dermatologist or surgeon.
- Pregnancy is commonly considered a relative contraindication for elective aesthetic procedures; many clinics defer non-essential laser treatments until after pregnancy and breastfeeding.
- Recent tanning, sunburn or use of self-tanning products in the treatment area, particularly for high-fluence Nd:YAG or KTP treatments, due to increased risk of pigmentary changes.
- History of keloid formation or abnormal scarring should be carefully assessed, especially for higher-energy or ablative procedures; treat only with caution and informed consent.
- Patients with unrealistic expectations or who cannot comply with post-treatment care, sun avoidance or treatment schedules.
- Use of the device when critical safety components (e.g. interlocks, fibre integrity, articulated arm alignment, KTP module) are damaged or malfunctioning.
Adverse Effects
- Transient erythema, oedema and warmth in the treated area are common and usually resolve within hours to a few days.
- Temporary darkening or lightening of skin (post-inflammatory hyperpigmentation or hypopigmentation), particularly in darker skin types or after sun exposure.
- Crusting, superficial epidermal damage or blistering if fluence, pulse duration or overlap are excessive or if appropriate cooling is not used.
- Pain or discomfort during treatment, typically manageable with cooling and/or topical anaesthesia depending on indication and parameters.
- Rare but serious risks include scarring, burns and long-term textural changes if the system is misused or parameters are inappropriate for the patient’s skin type and indication.
- Ocular injury, including permanent vision loss, if appropriate wavelength-specific eye protection is not used or beam control is inadequate.
- For onychomycosis and high-fluence nail procedures, risk of nail plate discomfort, temporary loosening or heat-induced pain if fluence and passes are not carefully controlled.
Storage Conditions
- Install and store the system in a clean, dry, temperature-controlled clinical environment, typically within standard room temperature and humidity ranges recommended by the manufacturer.
- Ensure adequate ventilation around the console for cooling; do not block air inlets or outlets.
- When not in use, power down the system according to the operator manual, protect handpieces and fibres from kinking or impact, and cover the device to reduce dust accumulation.
- Store laser safety eyewear near the system so it is always used when the laser is energised.
- If the system will be transported or stored for an extended period, secure moving parts, pack in manufacturer-approved crates or equivalent protective packaging and avoid exposure to shock, vibration, moisture or extreme temperatures.
Duration
Treatment duration and course depend on the indication: for hair reduction, typically multiple sessions spaced 4\u20138 weeks apart; for vascular and pigmented lesions, 1\u20133 or more sessions at several-week intervals; for onychomycosis, commonly 4 sessions at weekly or bi-weekly intervals; for resurfacing and scars (with Er:YAG where present), protocols vary from single to multiple sessions with weeks between treatments. Individual treatment times per session usually range from several minutes for small lesions to 30\u201360 minutes for large areas.
Onset
Some aesthetic effects such as vessel blanching or hair shaft damage may be visible immediately or within days of treatment, while full clinical results in hair reduction, photoaging, scars or onychomycosis typically develop gradually over weeks to months and may require multiple sessions.
