Non-invasive skin tightening and body contouring system (radiofrequency + ultrasound)
Certifications
CE Marked medical device in the EU/UK, indicating conformity with applicable European medical device directives and standards for safety and performance.
US FDA Cleared device for non Invasive dermatologic and aesthetic procedures including skin tightening, wrinkle reduction and body contouring using RF and ultrasound energy.
Manufactured by BTL Group of Companies under internationally recognised medical device quality systems and standards (including IEC 60601 Series for medical electrical equipment and proprietary Energy Flow Control technology).
CE Marked medical device in the EU/UK, indicating conformity with applicable European medical device directives and standards for safety and performance.
US FDA Cleared device for non Invasive dermatologic and aesthetic procedures including skin tightening, wrinkle reduction and body contouring using RF and ultrasound energy.
Manufactured by BTL Group of Companies under internationally recognised medical device quality systems and standards (including IEC 60601 Series for medical electrical equipment and proprietary Energy Flow Control technology).
Designed for use in compliance with local regulations governing operation of non Invasive energy Based aesthetic medical devices by appropriately trained professionals.
Description
BTL EXILIS ULTRA 360 is a non-invasive aesthetic medical device that simultaneously delivers monopolar radiofrequency and ultrasound energy to treat a wide range of concerns including skin laxity, wrinkles, excessive fat, cellulite and overall skin quality on both face and body. The system uses controlled volumetric heating and integrated cooling to safely heat dermal and subcutaneous tissues, stimulating collagen and elastin, triggering apoptosis of fat cells and improving circulation and tissue tone. It is indicated in many markets for non-invasive skin tightening and body contouring, and in the EU for obesity treatment by controlled reduction of fat cells and treatment of gynoid lipodystrophy (cellulite). This listing refers to a pre-owned EXILIS ULTRA 360 system purchased in November 2023 (approximately 2 years old) described as in immaculate, like-new condition, fully operational and ready for immediate clinical use, subject to verification of service history, calibration and support status with BTL or an authorised service provider.
Bnefits
First and only device platform from BTL that simultaneously combines monopolar radiofrequency and ultrasound in a single system for skin tightening and body contouring.
Non-invasive treatment of multiple conditions including wrinkles, skin laxity, excessive fat, cellulite and textural irregularities, from head to toe and for all skin types and BMI ranges.
360° volumetric heating and advanced Energy Flow Control technology for fast, homogeneous and controlled tissue heating, improving safety, comfort and consistency of outcomes.
Multiple applicators/tips designed for treatment of more than 20 anatomical areas, including face, neck, body and female intimate areas, providing high versatility in a single device.
US FDA-cleared and EU CE-marked system for non-invasive dermatologic and aesthetic procedures (skin tightening, fat reduction, cellulite appearance improvement), supporting regulatory confidence when used according to instructions for use.
Comfortable, no-downtime procedure often described as a warm massage; typically no anaesthesia or analgesia is required.
Short treatment times (around 15–45 minutes depending on area) with visible improvements often seen within 2–4 weeks, and continued improvements over 3–6 months as collagen remodelling occurs.
For a clinic purchasing this specific used unit, a late-model system (purchased November 2023) can provide full EXILIS ULTRA 360 capabilities at reduced capital cost, assuming validated maintenance and service.
Designed for use in compliance with local regulations governing operation of non Invasive energy Based aesthetic medical devices by appropriately trained professionals.
Non-invasive skin tightening and body contouring system (radiofrequency + ultrasound)
Indications
Non-invasive skin tightening and lifting of lax skin on the face, neck, décolleté and body.
Reduction in the appearance of wrinkles and rhytids.
Non-invasive body contouring and reduction of localized fat deposits in areas such as abdomen, flanks, thighs, arms and knees.
Improvement in the appearance of cellulite and skin surface irregularities.
General skin rejuvenation and improvement of texture, firmness and elasticity on multiple body areas.
In the EU and many markets, treatment of obesity and localized obesity by controlled reduction of fat cells, treatment of gynoid lipodystrophy (cellulite), skin laxity treatment, skin regeneration and alleviation of pain and muscle spasms, according to manufacturer indications.
Composition
Main EXILIS ULTRA 360 console housing the monopolar radiofrequency and ultrasound generators, integrated cooling system, control electronics and user interface.
Multiple applicators/handpieces with interchangeable 360° tips designed for different body and facial areas, combining RF electrodes and ultrasound transducers with contact cooling.
Grounding/return pad(s) and associated cables required for monopolar RF operation (depending on configuration).
Mobile trolley or cart for the console, enabling easy movement between treatment rooms.
Touchscreen user interface with pre-set treatment protocols, parameter adjustment, real-time temperature and impedance monitoring and safety controls.
Power cords, cables and connectors, as well as optional accessories and consumables (e.g. coupling gel/lotion) supplied according to original system configuration.
Formulation
Non-invasive energy-based aesthetic medical device combining monopolar radiofrequency and ultrasound technologies with integrated cooling.
Intended exclusively for professional use by trained medical or aesthetic practitioners in clinical, dermatological or medical spa settings.
Packaging
As a used system, typically supplied as a complete functional unit including: main EXILIS ULTRA 360 console, one or more handpieces/applicators with 360° tips, power cable, grounding pad cables (if required), and standard accessories as agreed between buyer and seller.
Original manufacturer crate or packaging may or may not be available; the buyer should confirm whether original transport packaging, user manuals and accessories are included.
Manufacturer documentation such as user manual and brochures may be supplied either as printed materials or PDF files.
Usage
Only clinicians or practitioners who have completed appropriate BTL EXILIS ULTRA 360 training should operate the device, following the official instructions for use and local regulations for medical/aesthetic devices.
Perform a full medical history and examination to confirm treatment suitability and rule out contraindications such as pregnancy, pacemakers, metal implants in the treatment area, active malignancy, severe systemic disease or active skin disease over the intended area.
Prepare the treatment area by ensuring skin is clean, dry and free of lotions, self-tanners or occlusive products; remove jewellery close to the treatment field and shave excess hair if recommended.
Apply a suitable coupling gel or lotion to the skin to facilitate optimal RF and ultrasound energy transfer and to protect the epidermis.
Select appropriate treatment protocol on the touchscreen (treatment area, skin type, desired outcome) and adjust parameters such as power, temperature targets and treatment time within manufacturer guidelines and patient comfort level.
Place the applicator on the skin and move it in continuous overlapping passes (circular or linear) over the treatment area, maintaining consistent contact and motion to achieve homogeneous heating; monitor real-time temperature feedback and patient sensation.
Typical courses require about 4–6 sessions per area, spaced approximately 7–14 days apart, with each session lasting about 15–45 minutes depending on the size and number of areas treated.
Throughout treatment, maintain communication with the patient to ensure the sensation remains within a tolerable warm/hot range but not painful; adjust energy or cooling settings as needed.
After the session, remove any remaining gel, inspect the skin (mild transient redness and warmth are expected) and provide aftercare advice, including adequate hydration and avoidance of aggressive topical treatments or heat exposure immediately after treatment.
For this pre-owned system, ensure it has undergone recent electrical safety testing, calibration and any necessary preventive maintenance by BTL or an authorised service provider before treating patients; maintain ongoing service and software updates per manufacturer recommendations.
Contraindications
Pregnancy and breastfeeding.
Presence of pacemaker, implanted defibrillator or other active implanted electronic medical devices.
Significant metal implants or metallic foreign bodies in or near the treatment area where monopolar RF and ultrasound could interact with metal structures.
Active malignancy or history of cancer in the treatment area, unless specifically cleared by an appropriate physician and consistent with local guidelines.
Active skin infections, open wounds, burns, severe varicose veins, severe inflammation or dermatologic conditions (e.g. active eczema, psoriasis, severe dermatitis) in the intended treatment area.
Severe uncontrolled systemic diseases including significant cardiovascular disease, uncontrolled diabetes, severe liver or kidney disease or major immune compromise.
Recent (or ongoing) use of systemic medications, photosensitising agents or therapies that significantly affect wound healing or tissue response, where contraindicated by the manufacturer.
Recent deep chemical peels, ablative laser resurfacing, surgery or substantial trauma in the treatment area that has not fully healed.
Bleeding disorders or use of anticoagulants that substantially increase bruising or bleeding risk where heat and mechanical stress could exacerbate issues.
Neurological or sensory disorders affecting the treatment area such that the patient cannot accurately report heat or discomfort, increasing risk of overheating.
Any additional conditions listed in the official EXILIS ULTRA 360 instructions for use as contraindications or warnings, or judged unsuitable by the supervising clinician.
Adverse Effects
Common transient effects such as local warmth, erythema (redness), mild oedema and a sensation of heat in the treated area immediately after treatment.
Mild tenderness, tightness or soreness of the treated tissues analogous to post-exercise or post-massage sensations.
Occasional superficial bruising, especially in individuals with fragile capillaries or on higher energy settings.
Temporary alterations in skin sensation (tingling, numbness or hypersensitivity) in or around the treated area, usually resolving spontaneously.
Very rare risk of superficial burns, blisters, excessive oedema or pigment changes if device parameters, movement or cooling are not properly managed or if patient feedback is impaired.
As with all aesthetic procedures, potential dissatisfaction with cosmetic outcome or asymmetry if expectations are unrealistic or if other underlying factors (e.g. weight fluctuation, lifestyle) are not optimised.
Storage Conditions
Install and operate the EXILIS ULTRA 360 system in an indoor clinical environment within the environmental conditions specified by BTL (typically around 10–30 °C and non-condensing relative humidity).
Place the device on a stable, level surface or dedicated cart, ensuring adequate ventilation around all vents and avoiding blockage of cooling airflow.
Disconnect from mains power and appropriately cover the device when not in use for extended periods to protect against dust and accidental damage.
Avoid exposure to water, high humidity or corrosive cleaning agents; clean the console and applicators only with manufacturer-approved disinfectants and according to the instructions for use.
Store handpieces, cables and accessories carefully to prevent kinking, crushing or mechanical stress on connectors and hoses.
Maintain regular preventive maintenance, calibration checks, and safety testing through BTL or an authorised service provider, documenting service dates and any repairs as part of the clinic’s equipment quality management system.
Duration
Most protocols recommend a series of approximately 4\u20136 treatment sessions per area, scheduled at 1\u20132 week intervals. Individual sessions typically last between 15 and 45 minutes depending on the size and number of areas treated. Clinical improvements evolve over several weeks to months after the treatment series, with many providers recommending maintenance sessions (for example every 3\u201312 months) based on patient response and goals.
Onset
Some patients notice initial skin tightening or textural improvement after the first few sessions, with more visible results generally developing within 2\u20134 weeks after starting treatment and continuing to improve over 3\u20136 months as collagen and elastin remodelling, fat cell apoptosis and tissue reorganisation progress.
