Ellman Pelleve Radio Frequency Facial Wrinkle Reduction System
Pellevé
Medical aesthetic device – radiofrequency skin tightening systemNon-ablative monopolar/bipolar RF wrinkle reduction and skin tightening platform
Certifications
- Pellevé RF system awarded European CE Mark (medical device) in 2005 for aesthetic skin tightening applications.
- FDA 510(k) clearance (granted in 2009) for non Ablative treatment of mild to moderate facial wrinkles and rhytids.
- PelleFirm RF body treatment system (body handpieces powered by the Pellevé S5 RF generator) holds CE Mark for body skin tightening and cellulite reduction and FDA 510(k) clearance for tissue heating and temporary reduction in the appearance of cellulite.
- Manufactured and distributed under applicable medical device regulations and quality management standards (e.g. ISO 13485) for RF Based medical devices, subject to local regulatory requirements.
- Requires installation, maintenance and use in accordance with electrical safety standards and clinical governance policies in the jurisdiction of use (e.g. IEC standards for medical electrical equipment).
- Pellevé RF system awarded European CE Mark (medical device) in 2005 for aesthetic skin tightening applications.
- FDA 510(k) clearance (granted in 2009) for non Ablative treatment of mild to moderate facial wrinkles and rhytids.
- PelleFirm RF body treatment system (body handpieces powered by the Pellevé S5 RF generator) holds CE Mark for body skin tightening and cellulite reduction and FDA 510(k) clearance for tissue heating and temporary reduction in the appearance of cellulite.
- Manufactured and distributed under applicable medical device regulations and quality management standards (e.g. ISO 13485) for RF Based medical devices, subject to local regulatory requirements.
- Requires installation, maintenance and use in accordance with electrical safety standards and clinical governance policies in the jurisdiction of use (e.g. IEC standards for medical electrical equipment).
Non-ablative monopolar/bipolar RF wrinkle reduction and skin tightening platform
Description
The Ellman Pelleve Radio Frequency Facial Wrinkle Reduction System (commonly referred to as the Pellevé S5 RF Wrinkle Reduction System) is a non-ablative radiofrequency (RF) aesthetic platform designed to improve mild to moderate facial wrinkles and skin laxity. Using patented 4.0 MHz RF technology, the GlideSafe handpieces deliver controlled dermal heating while preserving the epidermis, causing existing collagen fibres to contract and stimulating new collagen formation. The system is powered by an Ellman Pellevé S5 RF generator that can also support additional RF handpieces, including larger body-treatment handpieces (PelleFirm / body GlideSafe tips) to extend treatments beyond the face to areas such as the abdomen, thighs, arms and buttocks for body skin tightening and cellulite reduction.
Bnefits
- Non-surgical, non-ablative treatment of mild to moderate facial wrinkles using controlled radiofrequency energy.
- Improves skin laxity and texture through collagen contraction and neocollagenesis in the dermis.
- Minimal downtime with most patients returning immediately to normal activities after treatment.
- Treatments are generally well tolerated and often described as having a warming, massaging sensation rather than significant pain.
- GlideSafe handpieces with contact sensor enhance treatment safety by stopping energy delivery when contact is lost.
- Multiple handpiece sizes allow customised treatment of different facial areas and small regions with precision.
- S5 generator platform can be expanded with additional RF handpieces for surgical applications and for body skin tightening and cellulite treatment (e.g. PelleFirm body handpieces).
- CE Marked in Europe (Pellevé system) and FDA 510(k)-cleared in the US for non-ablative treatment of mild to moderate facial wrinkles and, with PelleFirm body system, for tissue heating and temporary reduction in the appearance of cellulite.
Indications
- Non-ablative treatment of mild to moderate facial wrinkles and rhytids (FDA-cleared indication).
- Cosmetic correction and reduction of facial skin laxity, including laxity under the chin and along the jawline.
- Skin tightening and improvement of skin quality on the face, including around the eyes (crow’s feet, upper eyelid excess skin).
- Softening of nasolabial folds, perioral lines, glabellar lines and forehead wrinkles.
- When used with compatible body-treatment handpieces (e.g. PelleFirm), non-invasive body skin tightening and temporary reduction in the appearance of cellulite on areas such as abdomen, buttocks, thighs and arms (CE Marked for body skin tightening and cellulite reduction; FDA 510(k) clearance for tissue heating and temporary reduction in the appearance of cellulite).
Composition
- Energy source: radiofrequency (RF) energy operating typically at 4.0 MHz for monopolar aesthetic treatments and approximately 1.7 MHz for bipolar mode, depending on configuration.
- System components: Pellevé S5 RF generator console, GlideSafe monopolar facial handpieces in multiple diameters, neutral/return electrode, connection cables and footswitch (depending on configuration).
- Optional components: larger RF handpieces and massage-tip handpieces for body treatment (PelleFirm or equivalent body handpieces), additional surgical handpieces and electrodes for RF surgical procedures (incision, coagulation) when the platform is configured for surgical use.
- Interface and controls: generator front panel with power adjustment, treatment modes and indicators, plus audible and/or visual feedback features.
- Consumables and accessories: RF coupling/contact gel for treatment area, disposable neutral pads (if required by configuration) and handpiece tips where applicable.
Formulation
- Medical device type: non-ablative RF energy-based aesthetic and surgical platform.
- Technology: monopolar (and optionally bipolar) radiofrequency energy at approximately 4.0 MHz, delivering gradual dermal heating while sparing the epidermis.
- Treatment delivery: GlideSafe handpieces that move across the skin with coupling gel, incorporating a contact sensor to interrupt RF delivery when adequate contact is not maintained.
- Facial handpiece sizes: multiple tip diameters (e.g. 7.5 mm, 10 mm, 15 mm and 20 mm) to allow treatment of small and larger facial areas including periorbital, perioral and submental regions.
- Body treatment: with compatible body handpieces, continuous monopolar RF delivery to larger body areas combined with mechanical massage (PelleFirm) for body skin tightening and cellulite improvement.
- Platform: compact RF generator designed for use in aesthetic clinics, dermatology and plastic surgery practices and other medical settings.
Packaging
- Typically supplied as a generator platform (Pellevé S5 RF generator) plus a selected set of GlideSafe facial handpieces and accessories, depending on configuration and distributor offering.
- Standard system configuration usually includes the RF generator, power cord, one or more GlideSafe facial handpieces, neutral/return electrode, footswitch and basic accessory kit.
- Additional handpieces for facial or body treatment (e.g. PelleFirm body handpieces) can usually be purchased separately to expand treatment capabilities.
- Packaged as a capital medical device system in protective shipping crates or boxes with documentation, including user manual, installation and maintenance information.
- Sold and installed by authorised distributors or directly by the manufacturer (or its successor), often with optional service and maintenance contracts.
Usage
- The Pelleve RF Wrinkle Reduction System is intended for use only by trained healthcare professionals or appropriately trained aesthetic practitioners working under medical supervision.
- Before treatment, the practitioner cleanses the treatment area thoroughly and applies an appropriate RF coupling/contact gel to facilitate smooth handpiece movement and energy transmission.
- The practitioner selects the appropriate handpiece size for the target area (e.g. small tip for periorbital lines, larger tips for cheeks or submental region) and sets the desired RF power parameters on the generator according to training and treatment protocols.
- During treatment, the practitioner moves the GlideSafe handpiece over the skin in small overlapping passes while gradually heating the dermal tissue; the handpiece’s contact sensor helps stop energy delivery if adequate skin contact is lost.
- Patients typically feel a deep warming sensation; the practitioner may rely on both patient feedback and skin temperature monitoring (e.g. infrared thermometer) to ensure therapeutic but safe temperatures are achieved.
- A full-face treatment session usually takes between 30 and 60 minutes, depending on the size and number of areas treated.
- For body treatments using compatible body handpieces, continuous RF delivery is combined with mechanical massage over larger areas such as thighs, buttocks or abdomen, following manufacturer treatment protocols.
- Post-treatment, mild erythema or swelling may be cooled with a gel pack or cooling mask; most patients can immediately resume normal activities and may apply makeup as advised by the practitioner.
- Typical treatment regimen for facial wrinkles is a series of 2–3 sessions spaced about 1 month apart, followed by periodic maintenance treatments as recommended by the practitioner based on patient response.
- Users must follow the manufacturer’s instructions for device setup, safety checks, handpiece maintenance, neutral pad placement (if applicable) and infection control procedures.
Contraindications
- Presence of active implanted electronic devices such as pacemakers, defibrillators or certain neurostimulators, due to potential interference with device function.
- Significant metallic implants in or near the treatment area (e.g. certain metal plates, screws or prostheses) that could heat during RF exposure, unless cleared by an appropriate specialist.
- Pregnancy or breastfeeding – although specific harm has not been established, most protocols recommend postponing cosmetic RF treatments until after pregnancy and lactation.
- Active skin infections, open wounds, severe inflammatory dermatoses or compromised skin barrier in the intended treatment area.
- Known hypersensitivity or intolerance to any topical products or coupling gels required for treatment when suitable alternatives are not available.
- History of abnormal wound healing, keloid formation or significant connective tissue disorders where dermal heating may pose additional risks, unless carefully evaluated by a physician.
- Uncontrolled systemic disease (e.g. unstable cardiac disease, poorly controlled diabetes) where elective aesthetic procedures may be inadvisable.
- Recent dermal filler injections or certain other energy-based procedures in the same treatment area, where manufacturer guidelines and clinical judgement advise caution or specific waiting periods.
- Use in patients who cannot accurately communicate sensation or discomfort levels (without suitable monitoring) may be relatively contraindicated due to the reliance on patient feedback during treatment.
Adverse Effects
- Common, usually mild and transient effects include erythema (redness), warmth and mild oedema (swelling) in the treated area, typically resolving within a few hours up to 24 hours.
- Some patients may experience temporary skin tenderness, tightness or a sensation similar to mild sunburn after treatment.
- Less commonly, superficial burns, blistering, focal overheating or prolonged erythema may occur if energy delivery or technique is inappropriate, if contact is inadequate or if cooling/monitoring is insufficient.
- Rare adverse effects that have been reported with RF aesthetic treatments include transient hyperpigmentation or hypopigmentation, especially in darker skin types or when post-treatment sun protection is inadequate.
- Inappropriate use, failure to follow manufacturer instructions, or use in patients with contraindicated implanted devices or metallic implants may lead to more serious complications, including interference with implanted devices or localised injury due to metal heating.
- Discomfort or pain during treatment can occur if energy settings are too high or if the patient has low tolerance; adjustment of parameters and technique can usually mitigate this.
- As with any aesthetic procedure, there is a small risk of unsatisfactory cosmetic outcome or asymmetry requiring further treatments or alternative approaches.
Storage Conditions
- The Pellevé S5 RF generator and handpieces should be stored and operated in accordance with the manufacturer’s environmental specifications (typically in a clean, dry clinical environment within specified temperature and humidity ranges).
- Handpieces and cables should be handled carefully, protected from impact, kinking or immersion in liquids, and stored in appropriate holders or protective cases when not in use.
- Electrical equipment should be connected only to properly grounded power outlets and protected from fluid spills; cleaning and disinfection must follow manufacturer recommendations using compatible agents.
- All accessories, including neutral electrodes and disposable components, should be stored in their original packaging until use and kept away from excessive heat, moisture and direct sunlight.
- The system should be regularly inspected, calibrated and maintained according to manufacturer and local regulatory requirements, with service records kept up to date.
Duration
A single full-face Pellev\u00e9 session generally lasts around 30\u201360 minutes. Most protocols recommend a course of 2\u20133 treatments spaced approximately 4 weeks apart, with results that can last up to about 6 months or longer depending on individual skin condition, ageing and lifestyle factors. Maintenance sessions at intervals determined by the treating practitioner are commonly used to sustain results. Body treatments with compatible handpieces have similar session times per area and may require a series of sessions to optimise cellulite and skin tightening outcomes.
Onset
Many patients notice some degree of skin tightening and wrinkle softening immediately or shortly after the first treatment due to initial collagen contraction, with continued improvement over the subsequent weeks to months as new collagen is produced. Optimal outcomes are typically observed after completion of a recommended treatment series and can continue to evolve for several months.
