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Linerase Collagen Powder 1 x 100 mg

Linerase Collagen Powder 1 x 100 mg

LINERASE

Medical Device
  • Class III medical device in the European market based on Heterologous Type I Collagen (HTIC) for injectable use in aesthetic and regenerative medicine.
  • Manufactured under ISO 9001 and ISO 13485 Certified quality management systems for medical devices.
  • Conforms to applicable European medical device regulatory requirements for sterile injectable collagen products, including biocompatibility and safety testing.
  • Intended exclusively for professional use in compliance with local regulations governing injectable aesthetic and regenerative treatments.
Injectable Collagen Biostimulator / Skin Bioregeneration

Description

Linerase Collagen Powder 1 x 100 mg is a professional, injectable heterologous Type I collagen (HTIC) medical device developed for regenerative aesthetic medicine and skin bioregeneration. Each sterile glass vial contains 100 mg of micronised equine-derived Type I atelocollagen in powder form, which is reconstituted with saline before intradermal injection by qualified medical professionals. The micronised atelocollagen provides an optimal biological matrix that stimulates fibroblast activity, promotes physiological neocollagenesis and supports the regeneration and reconstruction of connective tissue in the dermis. This biostimulatory action improves skin density, elasticity and firmness, helping to reduce fine lines and wrinkles, improve skin tone, and soften scars and stretch marks. Linerase is Class III medical device collagen therapy used on the face, neck, décolleté, hands and other body areas affected by chrono- and photoageing, skin atrophy, hypotonia and post-traumatic or post-surgical imperfections. After treatment, the skin appears more elastic, compact and radiant, with gradual, natural-looking rejuvenation rather than volumetric filling.

Bnefits

  • Provides 100 mg of micronised, sterile heterologous Type I atelocollagen (equine) in each vial for powerful dermal biostimulation.
  • Stimulates fibroblast activity and endogenous collagen production, promoting physiological neocollagenesis and connective tissue regeneration.
  • Improves skin density, elasticity and firmness, helping to counteract chrono- and photoageing.
  • Reduces the appearance of fine lines and wrinkles and softens atrophic scars and stretch marks.
  • Enhances overall skin quality, leaving the skin more compact, elastic, toned and radiant after a course of treatments.
  • Versatile indications for face, neck, décolleté, hands and other body areas with laxity, scars or stretch marks.
  • Non-volumising collagen biostimulator, leading to natural, gradual rejuvenation without a filler-like bulk effect.
  • Fully biodegradable atelocollagen with high purity and biocompatibility, designed for excellent tolerability.
  • Recognised in aesthetic dermatology as a tissue biostimulation product (including award recognition in aesthetic dermatology markets).
  • Presented as a Class III medical device, manufactured under ISO 9001 and ISO 13485 quality systems for injectable collagen products.

Indications

  • Professional skin bioregeneration and biorevitalisation in adult patients with signs of skin ageing.
  • Treatment of chrono- and photoageing of the face, neck, décolleté and hands (loss of firmness, elasticity and density).
  • Improvement of skin atrophy, skin hypotonia and reduced skin elasticity related to ageing, congenital or post-traumatic causes.
  • Reduction of fine lines and superficial to moderate wrinkles by rebuilding dermal support.
  • Regeneration and reconstruction of atrophic scars (including some post-acne and post-surgical scars) and improvement of stretch marks (striae).
  • Supportive treatment to improve skin texture, tone and hydration in areas affected by tissue damage or irregularities.
  • Adjunctive regenerative treatment in aesthetic medicine where stimulation of collagen and dermal matrix is desired, as assessed by a qualified clinician.

Composition

  • Active ingredient: 100 mg micronised Heterologous Type I Collagen (HTIC), equine-derived atelocollagen, in sterile powder form per vial.
  • Form: Micronised, sterile, pyrogen-free collagen powder for injectable suspension after reconstitution.
  • Excipients: Collagen-only formulation (no added crosslinking agents or fillers; reconstituted with sterile saline solution immediately prior to use).

Formulation

  • Product type: Injectable collagen biostimulator / mesotherapy-style medical device.
  • Pharmaceutical form: Micronised Type I atelocollagen powder in a sterile glass vial.
  • Strength: 100 mg micronised heterologous Type I collagen per vial.
  • Source: Equine-derived atelocollagen (heterologous Type I collagen), highly purified and micronised.
  • Route of administration: Intradermal injection of the reconstituted suspension by trained medical professionals.
  • Class: Class III medical device for injectable use in regenerative aesthetic medicine.

Packaging

  • Primary packaging: 1 sterile glass vial containing 100 mg Type I atelocollagen powder (micronised heterologous collagen).
  • Closure: Rubber stopper with protective cap, designed to maintain sterility until opening.
  • Pack size: 1 x 100 mg vial per box for a single treatment course per prepared suspension (used for one patient session).
  • Outer packaging: Branded carton with product name, batch number, expiry date, storage instructions and manufacturer details.
  • Intended for professional use: Packaging and labelling specify that the product is for use by qualified healthcare professionals only.

Usage

  • For professional use only: Linerase must be prepared and administered exclusively by suitably trained and qualified medical professionals familiar with injectable collagen and aseptic technique.
  • Reconstitute the 100 mg collagen powder immediately before use with sterile saline solution (according to the manufacturer’s instructions for use) to obtain a homogeneous suspension suitable for intradermal injection.
  • Use the prepared suspension during a single treatment session for one patient; discard any unused product safely after the procedure and do not reuse.
  • Administer the product intradermally into the treatment areas (such as face, neck, décolleté, hands or other indicated body areas) following recommended injection patterns and depths for collagen biostimulation, in accordance with official protocols and local clinical guidelines.
  • The full treatment protocol commonly consists of a series of 2–4 sessions spaced approximately 14–21 days apart, with the exact number of sessions and intervals determined by the practitioner based on the patient’s skin condition and treatment goals.
  • Maintenance or repeat treatment cycles may be considered approximately every 6–12 months (or as clinically indicated) to sustain results, in line with professional judgement and patient response.
  • Do not combine the same treatment area with aggressive procedures such as deep chemical peels, ablative lasers or dermabrasion within a short time frame; if such procedures are planned, allow an appropriate interval as per clinical guidance and product recommendations.
  • Before treatment, perform a thorough clinical assessment, review medical history and discuss expected benefits, limitations and potential risks with the patient, obtaining informed consent.
  • Prepare and disinfect the skin according to standard aseptic protocols for injectable procedures; avoid injecting into areas with active infection, inflammation or skin disease.
  • After treatment, provide appropriate post-procedure care instructions (e.g. avoiding excessive heat, sun exposure, or manipulation of the treated area for a recommended period) and schedule follow-up visits to monitor clinical outcomes and tolerability.
  • Linerase is not intended for self-administration or home use under any circumstances.

Contraindications

  • Known hypersensitivity or allergy to collagen (particularly equine-derived collagen) or any component of the product.
  • Active skin infections or inflammatory skin conditions (e.g. active dermatitis, cellulitis, untreated acne or herpes) at or near the intended injection sites.
  • Pregnancy and breastfeeding, as a precautionary measure in aesthetic indications.
  • Ongoing systemic antibiotic therapy or significant systemic infection, unless a specialist deems treatment appropriate.
  • Severe autoimmune or connective tissue disorders where injectable collagen may be inadvisable, according to clinician assessment.
  • History of severe allergic or anaphylactic reactions to injectable biomaterials.
  • Coagulation disorders or current use of anticoagulant therapy where intradermal injections may pose increased risk, unless carefully assessed and managed by a physician.
  • Any general contraindication to intradermal injection procedures or mesotherapy-type treatments as determined by a qualified healthcare professional.

Adverse Effects

  • Transient local reactions at the injection site such as redness (erythema), swelling (oedema), tenderness, warmth or a mild burning sensation, which usually resolve within hours to a few days.
  • Minor bruising or haematoma formation at injection points due to needle penetration of small blood vessels.
  • Temporary itching or discomfort in the treated area during the early post-treatment period.
  • Formation of small papules, nodules or irregularities at injection sites, typically transient and improving as the product integrates and collagen remodelling occurs.
  • In rare cases, inflammatory reactions, prolonged oedema, hypersensitivity or allergic responses to collagen or other components.
  • Very rare risk of infection at the injection site if aseptic technique is not strictly followed.
  • As with other injectable aesthetic treatments, inappropriate injection technique may increase the risk of uneven results, contour irregularities or local complications; therefore treatment must be performed by adequately trained practitioners.
  • Patients should be instructed to contact their practitioner promptly if they experience severe, persistent or unusual symptoms following treatment.

Storage Conditions

  • Store in a cool, dry place according to the temperature range specified on the outer packaging (typically at controlled room temperature; do not freeze).
  • Keep the vials in their original carton to protect from light and physical damage until use.
  • Do not use after the expiry date printed on the packaging.
  • Maintain sterility: do not use if the vial, stopper or packaging is damaged, opened or shows signs of compromised integrity.
  • Once reconstituted, use the prepared suspension immediately during the same treatment session and discard any unused portion safely; do not store reconstituted product for later use.
  • Keep out of the reach and sight of children and unauthorised persons in a secure, professional environment.

Duration

A typical treatment course consists of approximately 2\u20134 sessions performed at intervals of about 14\u201321 days, with the exact regimen tailored to the patient\u2019s age, skin condition and clinical objectives. Improvements in skin quality and elasticity are usually maintained for several months, often around 6\u201318 months depending on individual factors and protocol, after which maintenance sessions or repetition of the full course (for example every 6\u201312 months) may be considered at the clinician\u2019s discretion.

Onset

Initial improvements in skin texture, elasticity and tone are often noticeable within a few weeks of starting treatment, with further enhancement observed over subsequent sessions as new collagen is synthesised. Visible bioregenerative results typically develop progressively over 2\u20133 weeks following each treatment cycle and can persist for many months, subject to patient-specific factors and lifestyle.

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