Dermapen 4™ Microneedling System (Medical Dermapen)
Dermapen
Aesthetic medical deviceAutomated microneedling pen for collagen induction therapy
Certifications
- CE Marked medical device for use within the European Union medical device regulatory framework (including CE marking of Dermapen 4 device and its sterile needle cartridges)
- ISO 13485 Certified quality management system for medical devices
- FDA Cleared as a Class II medical device for the treatment of facial acne scars in relevant markets
- Registered as a Class II medical device by certain national health authorities (for example, approval by Taiwan’s Ministry of Health and Welfare reported for Dermapen 4)
- Designed and marketed in compliance with applicable infection Control and single Use device standards for sterile needle cartridges
- CE Marked medical device for use within the European Union medical device regulatory framework (including CE marking of Dermapen 4 device and its sterile needle cartridges)
- ISO 13485 Certified quality management system for medical devices
- FDA Cleared as a Class II medical device for the treatment of facial acne scars in relevant markets
- Registered as a Class II medical device by certain national health authorities (for example, approval by Taiwan’s Ministry of Health and Welfare reported for Dermapen 4)
- Designed and marketed in compliance with applicable infection Control and single Use device standards for sterile needle cartridges
Automated microneedling pen for collagen induction therapy
Description
Dermapen 4™ is a professional, medical-grade automated microneedling pen used by doctors, nurses and trained aesthetic practitioners for collagen induction therapy. The device uses a revolutionary 16-needle disposable cartridge driven by Advanced Oscillating Vertical Needle™ (AOVN™) technology to create millions of fine, vertical micro-channels in the skin. With adjustable needle depth (up to 3.0 mm in the medical version), digital speed control, dedicated scar-treatment algorithms and Bluetooth-enabled software, Dermapen 4 delivers fast, precise and reproducible treatments for a wide range of facial and body skin concerns. The system is CE-marked, ISO 13485 compliant and FDA-cleared for the treatment of facial acne scars, and is positioned as the flagship microneedling pen within the DermapenWorld portfolio.
Bnefits
- Advanced microneedling device designed specifically for medical and professional aesthetic use
- Creates up to approximately 1,920 micro-channels per second for shorter treatment times and faster visible results
- Adjustable needle depth (up to around 3.0 mm in the medical version) and multiple speed levels for fully customisable treatments
- Dedicated Scar Treatment (ST) setting with autocalibration of speed and depth for the revision of acne, surgical, contracture and stretch-mark scars
- Revolutionary 16-needle, surgical-steel cartridge that glides smoothly over the skin while maximising channel density with minimal discomfort
- Advanced Oscillating Vertical Needle™ (AOVN™) technology for precise perpendicular needle entry, reduced skin trauma and consistent penetration
- Anti-Contamination Management™ (ACM) and built-in fluid guard mechanisms to prevent fluid backflow, cross-contamination and drag
- Digital display with one-touch controls to adjust speed, depth and treatment modes easily during procedures
- Dual power operation (cordless battery operation or cabled use) for flexibility in clinical environments
- Bluetooth connectivity and docking options for firmware updates, device calibration and streamlined warranty/registration processes
- Clinically proven improvements in wrinkles, fine lines and acne scarring when used in protocol with Dp Dermaceuticals™ products
- Versatile protocols suitable for face and body, enabling treatment of multiple skin concerns in a single platform
- Minimal downtime compared with many ablative resurfacing procedures, with most patients able to resume normal activities quickly
Indications
- Facial acne scars (FDA-cleared indication in several markets)
- Atrophic and hypertrophic scarring including post-surgical and traumatic scars (according to dedicated scar treatment protocols)
- Stretch marks (striae distensae) on body areas such as abdomen, thighs and breasts
- Fine lines and wrinkles and general signs of skin ageing
- Photoageing and sun-damaged skin with uneven tone and texture
- Hyperpigmentation and melasma as part of combined treatment plans
- Diffuse dyschromia and post-inflammatory hyperpigmentation (PIH), used cautiously with appropriate protocols
- Enlarged pores and coarse skin texture
- Rosacea and erythematous, reactive skin when protocols recommend non-heat-based collagen induction
- Skin laxity and loss of firmness of the face, neck and décolletage
- Certain forms of hair loss and scalp conditions as part of adjunctive microneedling protocols
- General collagen induction therapy for overall skin rejuvenation and radiance on face, neck, décolletage, hands and body
Composition
- Handpiece: electronically powered microneedling pen with ergonomic housing and integrated digital display
- Drive system: Advanced Oscillating Vertical Needle™ (AOVN™) direct-drive motor designed for high-speed, perpendicular needle insertion
- Needle cartridge: sterile, single-use 16-needle tip made from surgical-grade stainless steel (typically 33-gauge microneedles)
- Needle depth range: adjustable in fine increments, typically from approximately 0.2 mm up to 3.0 mm in the medical configuration
- Anti-contamination architecture: built-in fluid guard, AOVN™ retention valves and Anti-Contamination Management™ system to prevent backflow and cross-contamination
- Electronics: integrated microcontroller with digital control of speed, depth and dedicated treatment modes including scar algorithms
- Power: dual-mode power system enabling cordless operation via rechargeable lithium-ion batteries or use via mains power with compatible power supply
- Connectivity: Bluetooth module capable of pairing with DermapenWorld apps and Dp DOCK™ for firmware updates, calibration and device management
- Accessories (depending on kit): charging dock or Dp DOCK™, USB or mains charger, power adapters, disposable sleeves, and associated cables
Formulation
- Electronic microneedling device (no pharmaceutical formulation). Treatments are typically performed in conjunction with Dp Dermaceuticals™ Meso-Glide serums and post-procedure skincare products designed specifically for use with Dermapen microneedling.
Packaging
- Professional device kits typically supplied in a branded presentation box or hard case containing the Dermapen 4 handpiece, power supply and accessories
- Starter or professional bundles may include Dermapen 4 handpiece, charging dock or stand, power adapters, USB or mains charger and protective sleeves
- Supplied with a limited number of sterile, single-use 16-needle cartridges (exact quantity varies by kit and distributor)
- Needle cartridges packaged individually in sterile, sealed blisters, CE-marked as medical devices and intended for single use only
- Professional packages may be bundled with Dp Dermaceuticals™ products such as TRI-PHASE CLEANSER™, HYLA ACTIVE™, VITAMIN RICH REPAIR™, COVER RECOVER™ or other Meso-Glide solutions and post-treatment masks
Usage
- For professional use only by appropriately trained and licensed healthcare or aesthetic practitioners, according to local regulations.
- Perform a full medical history, skin assessment and informed consent prior to treatment. Identify indications, contraindications and realistic expectations.
- Cleanse the treatment area thoroughly with an appropriate antimicrobial cleanser; remove make-up, oils and debris.
- Apply topical anaesthetic cream if indicated and permitted by local regulations; allow sufficient contact time, then remove completely and disinfect the skin.
- Prepare the device by attaching a new, sterile, single-use Dermapen 4 needle cartridge; confirm that the cartridge locks in place and the device recognises it correctly.
- Set the appropriate needle depth and speed based on the treatment indication, skin type, anatomical area and protocol (for example, lower depths around the periorbital region and higher depths for scars and thicker skin).
- Apply an appropriate Dp Dermaceuticals™ Meso-Glide serum or other approved glide medium to the treatment area to support needle glide and active ingredient delivery.
- Hold the skin taut and move the Dermapen 4 in systematic, overlapping passes (vertical, horizontal and oblique directions) to ensure full, even coverage without excessive pressure.
- For scar or stretch-mark revision, use the dedicated Scar Treatment (ST) setting and follow manufacturer-supplied protocols for depth, passes and frequency.
- Observe skin response throughout the procedure, monitoring for pinpoint bleeding, erythema and patient comfort; adjust depth and speed as required.
- After completing the passes, gently remove residual serum if indicated and apply post-treatment products such as soothing serums, hydrating masks and broad-spectrum sunscreen.
- Dispose of the used needle cartridge immediately in an appropriate sharps container and remove/dispose of any single-use protective sleeves according to infection-control policy.
- Clean and disinfect the handpiece and charging dock according to the manufacturer’s instructions using approved surface disinfectants.
- Provide written and verbal post-treatment care instructions, including sun protection, avoidance of irritating topical products for several days, and signs of complications that require medical review.
- Schedule follow-up sessions according to treatment goals (for example, every 4–6 weeks for general rejuvenation or as specified in scar-treatment protocols).
Contraindications
- Active local skin infection at the treatment site, including bacterial, viral (e.g. herpes simplex) or fungal infections
- Open wounds, ulcers, unhealed surgical sites or significant skin barrier disruption in the planned treatment area
- Active inflammatory skin diseases in the area such as severe acne, eczema, psoriasis or dermatitis unless specifically managed under specialist supervision
- History of keloid or hypertrophic scarring or abnormal wound healing, especially if treating high-risk areas
- Uncontrolled diabetes mellitus or significant immunosuppression that may impair healing
- Known bleeding disorders, platelet dysfunction or current use of anticoagulant or antiplatelet medications that significantly increase bleeding risk, unless cleared by a physician
- Recent use of oral isotretinoin within a time frame contraindicated by local guidelines and manufacturer protocols
- Pregnancy and breastfeeding are generally regarded as relative contraindications for elective aesthetic microneedling in many protocols
- History of active skin cancer or premalignant lesions in the planned treatment area unless managed by an appropriate specialist
- Active sunburn in the treatment area
- Known allergy or hypersensitivity to any topical products, serums or disinfectants planned for use during the procedure
- Any systemic illness, dermatologic or medical condition that the treating clinician judges to increase risk or impair healing
Adverse Effects
- Transient erythema, warmth and mild oedema at the treatment site lasting from several hours up to a few days
- Pinpoint bleeding during treatment and temporary petechiae or minor bruising, particularly in patients with fragile skin or on anticoagulant therapy
- Skin tightness, dryness or flaking for several days as part of normal post-treatment recovery
- Temporary increase in skin sensitivity to topical products, heat and UV exposure
- Risk of infection if aseptic technique, proper skin preparation and post-care are not followed
- Post-inflammatory hyperpigmentation, particularly in darker skin phototypes or when sun protection is inadequate
- Exacerbation of dormant herpes simplex infection (cold sores) in susceptible patients if prophylaxis is not used
- Very rare risk of scarring or textural change if inappropriate needle depths, excessive passes or improper technique are used
- Allergic or irritant reactions to topical anaesthetics, glide serums, post-treatment products or disinfectants used during the procedure
Storage Conditions
- Store the Dermapen 4 handpiece and accessories in a clean, dry environment at typical room temperature away from direct sunlight and sources of heat or moisture.
- Keep the device in its protective case, dock or stand when not in use to protect against impact, dust and contamination.
- Store sterile, single-use needle cartridges in their original, sealed blister packaging until immediately before use, at room temperature and away from contaminants.
- Do not use needle cartridges if packaging is damaged, opened or past the manufacturer’s expiry date.
- Ensure the rechargeable batteries are charged and maintained according to the manufacturer’s instructions; avoid exposure to extreme temperatures.
- Clean and disinfect the external surfaces of the handpiece, dock and cables after each use with compatible disinfectants, then allow them to dry completely before storage.
Duration
Typical Dermapen 4 treatments last approximately 20\u201360 minutes per session depending on the size of the area and indication. A course of around 3\u20136 sessions spaced at 4\u20136 week intervals is commonly recommended for general rejuvenation, with additional sessions often required for more resistant scarring or stretch marks. Maintenance treatments may be performed periodically thereafter according to clinical judgement and patient goals.
Onset
Most patients notice initial improvements in skin radiance and texture within days to a few weeks after the first treatment as post-inflammatory erythema settles. Collagen remodelling is progressive, with more significant improvement typically visible after a series of treatments over 6\u201312 weeks and ongoing collagen maturation over several months. Scar and stretch-mark revision usually requires multiple sessions before maximal benefits are seen.
