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Dermapen Cryo™

Dermapen Cryo™

Dermapen

Cryotherapy device
  • Historically marketed and labeled as CE and FDA registered; however, a UK MHRA Medical Device Alert (MDA/2019/028) concluded that Dermapen Cryo devices were manufactured to unknown standards and that the CE mark on packaging had not been obtained through appropriate regulatory oversight.
  • The MHRA alert advised that all affected Dermapen Cryo devices should be identified and not used on patients, as their safety could not be verified.
  • Alert documentation notes that Dermapen devices were manufactured by Equipmed (trading as DermapenWorld Pty Ltd, Equipmed USA, Equipmed Europe Limited, or Equipmed International Pty) and distributed in the UK by Naturastudios.
  • Dermapen Cryo is identified as a trademark of Equipmed in official patient brochure materials, which also describe the device’s intended purpose and cryotherapy parameters.
  • Clinics and marketing materials outside the UK have described Dermapen Cryo as both CE and FDA registered, but practitioners must check current regulatory status and local medical device requirements before use.
  • In some markets, distributors have discontinued marketing Dermapen Cryo and replaced it with alternative cryotherapy devices that hold validated CE and/or FDA approvals.
Nitrous oxide cryotherapy pen for benign skin lesions

Description

Dermapen Cryo™ is a handheld, pen-like nitrous oxide (N2O) cryotherapy device designed for the targeted destruction of benign skin lesions in aesthetic and dermatology practices. Using a precise, high-pressure jet of liquefied N2O delivered through interchangeable applicator tips, the device rapidly freezes intercellular fluid within the lesion, forming ice crystals that rupture cell membranes and lead to controlled tissue destruction. It is intended for cosmetic removal of common benign lesions such as warts, skin tags, age spots, benign moles approved by a physician, and certain superficial pigmented lesions. Treatments are quick (typically seconds), with minimal downtime, and the device is marketed for use by trained clinicians seeking a portable alternative to traditional liquid nitrogen cryosurgery. However, UK regulators have issued a Medical Device Alert advising that Dermapen Cryo devices were manufactured to unknown standards and should not be used, as their CE mark was not obtained through appropriate regulatory oversight.

Bnefits

  • Portable, pen-like design that allows precise cryotherapy in a clinic or aesthetic practice setting.
  • Delivers a focused, high-pressure jet of liquefied nitrous oxide for pinpoint accuracy with minimal damage to surrounding tissue.
  • Intended to treat a range of benign skin lesions, including skin tags, viral warts, age spots, benign moles (when medically assessed), and certain hyperpigmented lesions.
  • Quick treatment times, typically from 1 to 30 seconds per lesion depending on size and thickness, enabling multiple lesions to be treated in a single session.
  • Penetration rate of approximately 1 mm of tissue depth per 5 seconds of application, with a maximum depth of around 3–6 mm depending on the applicator tip.
  • Minimal downtime, with most patients able to resume normal activities immediately after treatment.
  • Designed to deliver nitrous oxide directly to the lesion, sparing the surrounding healthy skin as much as possible.
  • Uses disposable N2O cartridges and tips to support convenience and limit cross-contamination when correctly used with appropriate infection-control protocols.
  • Historically marketed as CE and FDA registered, positioning it as a medical-grade device in many clinics (though this status has been challenged by subsequent regulatory findings).
  • Suitable as an add-on service in aesthetic businesses to expand treatment menus beyond microneedling and topical procedures.

Indications

  • Cosmetic removal of benign epidermal and superficial dermal lesions assessed as suitable for cryotherapy by a qualified clinician.
  • Skin tags (acrochordons).
  • Common and plantar warts (verrucae) and other benign viral warts.
  • Seborrheic keratoses and certain age or sun spots (solar lentigines) when appropriate for cryotherapy.
  • Benign moles that have been examined and cleared for treatment by a medical doctor (no suspicious or malignant features).
  • Cherry angiomas and other small benign vascular lesions at the clinician’s discretion.
  • Resistant localised hyperpigmentation lesions that are suitable for targeted cryotherapy.
  • Lesions on face, neck, trunk, and extremities where controlled cryotherapy is clinically appropriate and safe.
  • Use only on lesions confirmed benign; suspicious, changing, or atypical lesions must be referred for medical evaluation rather than treated cosmetically.

Composition

  • Handheld cryotherapy device with pen-like plastic/metal housing and integrated trigger/on–off control.
  • Pressurised disposable nitrous oxide (N2O) cartridges, typically 8 g medical-grade N2O, providing the cryogen for treatment.
  • Interchangeable stainless-steel or metal applicator tips designed to concentrate and direct the N2O jet for various lesion sizes and flow rates.
  • Internal pressure-regulation and microvalve system to generate a fine, high-pressure jet of liquefied N2O at approximately −89°C at the treatment tip.
  • Foam-lined storage and transport case, plus accessories such as spare applicators and cartridge holder where supplied.
  • User manual and patient information materials outlining indications, contraindications, and safe use of cryotherapy.

Formulation

  • Device-based treatment: no pharmaceutical formulation is injected or applied inside the lesion; tissue destruction is achieved by extreme cold from liquefied nitrous oxide.
  • N2O is stored under pressure in sealed, single-use metal cartridges inserted into the device body prior to treatment.
  • Upon activation, the system releases a metered jet of liquefied N2O through a fine applicator tip, rapidly cooling tissue by freezing intracellular and extracellular fluid.
  • Cryogenic effect leads to ice crystal formation, cell membrane rupture, vascular stasis, and subsequent necrosis of the target lesion.
  • Thermal effect is localized by the small-diameter tip and limited application time to minimise damage to adjacent, healthy skin.
  • Designed for repeated cartridge replacement while the main handpiece is retained and re-used following appropriate cleaning and maintenance as per the user manual.

Packaging

  • Standard kit typically supplied in a rigid, foam-lined carry case containing the Dermapen Cryo handpiece and accessory components.
  • Includes one or more interchangeable applicator tips sized for different lesion diameters and treatment depths.
  • Supplied with a starter set of disposable N2O cartridges (quantity may vary by distributor or kit version).
  • Printed user manual/instructions for use, and often patient information brochures for in-clinic counselling.
  • Outer labeling typically displays device name, manufacturer/trademark (Dermapen Cryo™ / Equipmed), contact details, and regulatory symbols (including CE mark on historical stock).
  • Some distributors may bundle training material or access to online resources as part of a professional starter package.

Usage

  • Dermapen Cryo™ is intended for use only by trained healthcare professionals or aesthetic practitioners familiar with cryotherapy and cutaneous lesion assessment.
  • Before treatment, each lesion must be clinically assessed and, where appropriate, confirmed by a medical doctor as benign; suspicious moles or lesions with atypical features must not be treated.
  • The operator selects an appropriate applicator tip based on lesion size and desired treatment depth, then inserts a fresh N2O cartridge into the device according to the user manual.
  • The tip is positioned perpendicularly over the lesion and activated to deliver a focused jet of liquefied nitrous oxide; freezing is generally applied for 1–30 seconds depending on lesion thickness and type.
  • Typical freezing penetration rate is approximately 1 mm per 5 seconds, with a maximum freezing depth of about 3–6 mm depending on the applicator; application time should be chosen accordingly.
  • One or more freeze–thaw cycles may be used based on lesion characteristics and local protocol, ensuring adequate thawing between cycles.
  • During treatment, care is taken to confine the spray to the lesion, avoiding surrounding healthy skin, sensitive structures, and superficial nerves.
  • The patient may feel intense cold and a stinging or pricking sensation during freezing; discomfort generally subsides shortly after treatment.
  • Post-procedure, the treated area may blister, crust, or darken before sloughing off; patients should be advised not to pick at scabs and to keep the area clean and protected from trauma and sun.
  • Follow-up is typically scheduled 2–4 (up to 2–8) weeks after treatment to assess lesion clearance and determine if an additional cryotherapy session is required.
  • Additional caution and shorter freeze times (e.g., repeated 3–6 second cycles) are recommended for darker skin types to reduce the risk of hypo- or hyperpigmentation.
  • The device and accessories should be cleaned and maintained in line with manufacturer instructions; cartridges are single-use and must be discarded safely after depletion.
  • Operators should wear appropriate protective equipment (e.g., gloves, eye protection) and ensure adequate ventilation when using N2O cartridges.
  • Do not use the device if damaged, malfunctioning, or if regulatory alerts in your jurisdiction advise against its use.

Contraindications

  • Suspicious, changing, or atypical pigmented lesions, or lesions where malignancy (e.g., melanoma, squamous cell carcinoma, basal cell carcinoma) cannot be confidently excluded; these require medical evaluation rather than cosmetic cryotherapy.
  • Untreated or histologically unconfirmed moles unless specifically reviewed and approved by a medical physician.
  • Known hypersensitivity or intolerance to cold (e.g., cold urticaria, cryoglobulinaemia, cold agglutinin disease).
  • Conditions with markedly impaired peripheral circulation, such as severe peripheral vascular disease or uncontrolled diabetes with vascular compromise.
  • Impaired local sensation or neuropathy (e.g., advanced diabetic neuropathy), where the patient cannot adequately perceive cold or pain.
  • Presence of superficial nerves near the intended treatment site (e.g., certain locations on fingers, wrists, behind the ear) where there is an increased risk of nerve damage without appropriate modification of technique.
  • Active infection, open wounds, or dermatitis in or around the treatment area.
  • Known history of poor wound healing, keloid or hypertrophic scar formation in the treatment region, where cryotherapy may increase scarring risk.
  • Patients with significant cardiac disease or other systemic illnesses in whom additional stress or vasoconstriction from cold exposure is considered contraindicated by their physician.
  • Very dark skin types where the risk of hypo- or hyperpigmentation is unacceptable and alternative treatments are preferred.
  • Pregnancy and breastfeeding are commonly listed as precautionary or relative contraindications due to limited data; decisions should be made on an individual risk–benefit basis by a qualified clinician.
  • Inability of the patient to provide informed consent or comply with aftercare instructions.
  • Use in jurisdictions where regulatory authorities (e.g., MHRA in the UK) have specifically advised that Dermapen Cryo devices should not be used due to concerns regarding manufacturing standards and lack of valid CE marking.

Adverse Effects

  • Immediate transient pain, stinging, or burning sensation at the treatment site during and shortly after freezing.
  • Erythema (redness), swelling, and edema around the treated lesion.
  • Blister formation (serous or haemorrhagic) over the lesion, which may subsequently rupture and crust.
  • Crusting, scabbing, and temporary darkening or lightening of the treated area as the lesion resolves.
  • Pigmentary changes, including hypopigmentation or hyperpigmentation, particularly in darker skin types or with aggressive freezing.
  • Local infection if blisters or crusts are picked, traumatised, or inadequately cared for post-treatment.
  • Scarring, including hypertrophic or atrophic scars, especially with overly deep or prolonged freeze times.
  • Nerve damage (neuropraxia) presenting as temporary or, rarely, permanent numbness, tingling, or altered sensation when nerves lie close to the skin surface or freeze parameters are excessive.
  • Hair follicle damage and potential permanent alopecia when lesions in hair-bearing areas are treated.
  • Minor shards of frozen ice possibly being expelled from the treatment site; these fragments thaw on contact with warm skin but can cause brief discomfort.
  • Very rare risk of more serious complications if cryotherapy is inadvertently applied to inappropriate lesions or anatomical areas, underscoring the need for proper training and lesion selection.
  • General risks inherent to nitrous oxide cartridge use (e.g., cold burns to operator or patient if mishandled, and risk of cartridge rupture if stored or used incorrectly).

Storage Conditions

  • Store the Dermapen Cryo device and accessories in a clean, dry environment at room temperature, away from moisture and corrosive substances.
  • Keep nitrous oxide cartridges in a cool, well-ventilated place away from direct sunlight, open flames, and sources of heat or ignition; cartridges are pressurised gas containers.
  • Do not expose N2O cartridges to temperatures above the maximum specified on the packaging (commonly around 50°C); avoid freezing the cartridges outside their intended operating conditions.
  • Protect the device and cartridges from impact, crushing, or puncture; damaged cartridges must not be used.
  • Keep all components out of the reach of children and unauthorised persons.
  • Store the handpiece in its supplied protective case when not in use to reduce the risk of mechanical damage and contamination.
  • Follow any additional storage and handling instructions provided in the official user manual for specific kit configurations and cartridge types.

Duration

Individual lesion freezing typically lasts from 1 to 30 seconds depending on lesion thickness and desired depth (approximately 1 mm penetration per 5 seconds, up to around 3\u20136 mm). Lesion clearance, including blistering, crusting, and shedding, usually occurs over 1\u20134 weeks, with follow-up commonly at 2\u20138 weeks. Successfully treated benign lesions are generally removed permanently, although new lesions can form over time and may require additional treatments.

Onset

Cryogenic tissue injury begins immediately during the freezing application, with visible whitening of the lesion within seconds. Clinical changes such as redness, swelling, blistering, and crusting develop over hours to days after treatment, while final cosmetic outcomes and lesion clearance are typically evident within several weeks.

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