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SkinPen® Precision Microneedling Device

SkinPen® Precision Microneedling Device

SkinPen®

Microneedling device
  • First microneedling brand to offer an FDA Cleared microneedling device for the treatment of facial acne scars in adults (as per SkinPen and Crown Aesthetics documentation).
  • CE Marked medical device (commonly Class IIa) for treatment of facial acne scars and aesthetic indications such as fine lines, wrinkles, stretch marks, surgical scars, enlarged pores and dyschromia, depending on regional labelling.
  • Manufactured under quality management systems consistent with applicable medical device standards (e.g., ISO 13485) and regulatory requirements in relevant markets.
  • Subject to ongoing clinical validation, post Market surveillance and safety/efficacy monitoring as part of Crown Aesthetics’ regulatory obligations.
Professional collagen induction therapy pen

Description

SkinPen® Precision is a professional, motorised microneedling device designed to perform collagen induction therapy (CIT) by creating controlled micro-channels in the skin. As the first FDA-cleared and CE-marked microneedling system, it is indicated to improve the appearance of facial acne scars in adults and wrinkles of the neck, and is widely used to enhance overall skin texture, fine lines, and skin quality. The device consists of a reusable handpiece and single-use sterile needle cartridges with adjustable depth, allowing clinicians to tailor treatments safely across multiple skin types with minimal downtime.

Bnefits

  • FDA-cleared and CE-marked microneedling device, supported by extensive validation and clinical studies.
  • Improves the appearance of facial acne scars in adults and wrinkles on the neck.
  • Helps improve cosmetic concerns such as fine lines, enlarged pores, uneven texture, dyschromia (pigmentation irregularities), surgical scars and stretch marks, depending on local indications.
  • Stimulates natural collagen and elastin production through controlled mechanical micro-injury without heat or chemicals, preserving the epidermis.
  • Suitable for all or most Fitzpatrick skin types when used according to instructions, with minimal downtime.
  • Digitally controlled, consistent needle depth and speed to enhance treatment precision and reproducibility.
  • Single-use, sterile needle cartridges and protective BioSheath coverings are designed to reduce cross-contamination risk and improve safety.
  • Can be combined with appropriate post-microneedling skincare protocols to optimise results and support barrier recovery.

Indications

  • Medical purpose: treatment to improve the appearance of facial acne scars in adults aged 22 years or older (as per FDA clearance and CE-marked indications).
  • Medical purpose: treatment to improve the appearance of wrinkles of the neck for specified Fitzpatrick skin types (per regional labelling).
  • Aesthetic purposes: improvement of the cosmetic appearance of fine lines and wrinkles on the face and neck.
  • Aesthetic purposes: improvement of the cosmetic appearance of stretch marks and surgical scars.
  • Aesthetic purposes: reduction in the appearance of enlarged pores and refinement of skin texture.
  • Aesthetic purposes: improvement in the cosmetic appearance of pigmentation irregularities (dyschromia), depending on local regulatory indications.
  • General skin rejuvenation and remodelling via collagen induction therapy, as assessed and performed by qualified practitioners.

Composition

  • Reusable powered handpiece (microneedling pen) constructed from medical-grade materials with an internal motor drive.
  • Sterile, single-use microneedling cartridges containing multiple fine stainless steel needles (needle count and configuration depend on cartridge model).
  • Adjustable needle depth mechanism (typically up to around 2–2.5 mm, depending on cartridge and indication) governed by the device settings.
  • Charging base and/or power supply unit, plus disposable BioSheath covers to protect the handpiece during treatment.
  • Materials and components are non-sterile for the handpiece and sterile for the single-use needle cartridges, as specified in the Instructions for Use (IFU).

Formulation

  • Non-implantable, powered Class II / Class IIa microneedling medical device system.
  • Pen-style handpiece with adjustable settings for needle depth and reciprocating needle movement at high speed.
  • Single-use, sterile needle cartridges designed to be locked into the handpiece and disposed of after each treatment.
  • Accessory components such as BioSheath barrier sleeves and Lift HG hydrogel (wound dressing) may be used according to protocol to reduce friction and protect the skin surface.

Packaging

  • Primary packaging for the device typically includes: SkinPen® Precision handpiece, charging base or power supply, and user manual/IFU.
  • Sterile single-use needle cartridges are supplied separately in sealed, sterile blister packs (often in multi-unit boxes) with clear labelling and expiry dates.
  • Some distributor or clinic bundles may include starter kits with the device, a quantity of cartridges, BioSheath covers and post-procedure products.
  • Outer cartons and inner packaging carry device identification, regulatory markings (including CE symbol and, where applicable, FDA-cleared labelling), batch/lot numbers and serial numbers for traceability.

Usage

  • SkinPen® Precision is for use only by trained and appropriately licensed healthcare professionals familiar with microneedling and the device IFU.
  • Before treatment, perform a full medical history, skin assessment and indication check; obtain informed consent and ensure realistic expectations.
  • Cleanse the treatment area thoroughly and disinfect according to clinical protocol; topical anaesthetic may be applied and removed as per clinic policy and local regulations.
  • Place a sterile BioSheath over the handpiece (if supplied/required) and install a new sterile single-use needle cartridge; verify secure attachment.
  • Select and set the appropriate needle depth and speed based on the treatment indication, anatomical area, skin thickness and patient tolerance.
  • Apply a suitable sterile glide or hydrogel (e.g., Lift HG or clinic-approved alternative) to the skin to reduce friction and support even movement.
  • Move the device across the skin in systematic passes (typically vertical, horizontal and oblique patterns) to create uniform micro-channels; avoid excessive pressure.
  • Monitor skin response continuously, aiming for uniform erythema and pinpoint bleeding as clinically appropriate without over-treating.
  • After treatment, remove and safely dispose of the needle cartridge and BioSheath as clinical sharps/biohazard waste; clean and disinfect the handpiece according to manufacturer’s recommendations.
  • Apply recommended post-procedure products and provide written aftercare instructions (e.g., sun avoidance, use of broad-spectrum sunscreen, avoidance of harsh products, and timing of makeup application).
  • Schedule follow-up sessions according to the treatment plan, typically spaced several weeks apart, and adjust parameters based on clinical response and patient comfort.
  • Always follow the latest official SkinPen® Precision Instructions for Use and local clinical guidelines for indications, contraindications, operating parameters and maintenance.

Contraindications

  • Active skin infections, inflammations or open wounds in the intended treatment area (e.g., bacterial, viral or fungal infections, active acne cysts, cold sores/herpes simplex).
  • Known history of keloid or hypertrophic scarring, or poor wound healing where microneedling risk is considered unacceptable.
  • Active skin cancer or pre-malignant lesions in the treatment area, unless cleared by the appropriate specialist.
  • Use of systemic isotretinoin (Accutane® or equivalents) within a timeframe specified in the IFU and clinical guidelines (often within the last 6–12 months).
  • Significant bleeding disorders or current use of anticoagulant therapy that may increase bleeding risk, unless carefully evaluated by the treating physician.
  • Pregnancy and breastfeeding, due to limited safety data and typical exclusion in cosmetic procedure protocols.
  • Autoimmune or immunosuppressive conditions where wound healing may be compromised, unless specifically assessed and approved by the treating physician.
  • Known allergy or hypersensitivity to topical products used during or after the procedure (e.g., certain gels, dressings or topical anaesthetics).
  • Any other condition or medication listed as a contraindication in the official SkinPen® Precision IFU or by local guidelines.

Adverse Effects

  • Expected transient effects such as redness (erythema), swelling and warmth in the treated area, typically resolving within 24–72 hours.
  • Mild discomfort, tightness, burning or stinging sensations during and shortly after the procedure.
  • Pinpoint bleeding and occasional bruising or petechiae, especially in sensitive or thin skin areas.
  • Dryness, flaking or mild exfoliation as the skin renews in the days following treatment.
  • Less common events can include prolonged erythema, oedema, post-inflammatory hyperpigmentation or hypopigmentation, particularly in darker skin types or with inadequate sun protection.
  • Rare but possible adverse events include infection, scarring, allergic reactions to topical products used during or after the procedure, or acneiform eruptions.
  • Any unexpected, persistent or severe reaction should be evaluated promptly and managed according to clinical judgement and the IFU guidance.

Storage Conditions

  • Store the device handpiece and accessories in a clean, dry environment at normal room temperature, in accordance with the manufacturer’s instructions.
  • Keep sterile needle cartridges in their original sealed packaging until immediately prior to use; protect from excessive heat, moisture and direct sunlight.
  • Do not use cartridges after the expiry date or if packaging is damaged or compromised.
  • Avoid exposing electrical components (handpiece, charging base and power supply) to liquids; follow recommended cleaning and disinfection procedures.
  • Ensure the device is unplugged when not in use and store it in a secure location, out of reach of unauthorised users or children.

Duration

Typical treatment courses for SkinPen\u00ae microneedling consist of a series of approximately 3\u20136 sessions spaced about 4 weeks apart, depending on indication and skin condition. Each in-clinic procedure usually takes around 30\u201360 minutes including preparation and aftercare, with optional maintenance sessions every 6\u201312 months or as clinically indicated.

Onset

Initial improvements in skin radiance and texture may be noticed within days to weeks after treatment as post-procedure erythema resolves, while more significant changes in acne scars and wrinkles typically develop gradually over several weeks to months as new collagen and elastin are formed during the wound-healing and remodelling process.

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