Raffine Micro-Needling

Raffine's automated Micro-Needle therapy system for Collagen Induction Therapy (CIT), represents a refined approach to dermatological treatments, designed to address a multitude of skin concerns non-surgically and with minimal trauma.

With its listing on the ARTG & CE medical certification, this device meets rigorous safety and health standards, ensuring it as a safe and efficacious choice for rejuvenating and repairing the skin.

Raffine’s patented technology harnesses the power of mechanical CIT with treatments tailored for an array of clinical skin presentations - such as signs of ageing, acne, scarring and hyperpigmentation.

The system is universally suitable for all skin types and can be utilised on the face, scalp, and body.

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What is Micro-Needling?

Micro-Needling, also known as percutaneous collagen induction therapy (PCIT), is a minimally invasive procedure that uses fine needles to rapidly penetrate the epidermis, creating many tens of thousands of micro-punctures per minute. This action induces regeneration of the dermal extracellular matrix via the wound-healing cascade.

How does Micro-Needling deliver its therapeutic benefit?

Published research and scientific literature have provided extensive resources on Micro-Needling’s mechanism of action and how it delivers a therapeutic benefit to the patient.

The principal action of Micro-Needling utilises ultra-fine needles that are pushed in and out of the skin from within the Micro-Needling cartridge, penetrating the stratum corneum to create small holes, known as micro-conduits, with minimal damage to the epidermis (Iriarte et al, 2017). This process can be delineated into three distinct phases:

Inflammation: Piercing the skin barrier triggers an immune response, which disinfects the wounds, removes debris, increases blood flow, and creates new tissue (Fabbrocini et al., 2009).

Proliferation: The wound is rebuilt with new granulation cells, which are part of the extracellular matrix. Moreover, a new network of blood vessels develops (Liechty et al., 2000).

Remodelling: The wound is replaced with new dermal tissues and blood vessels. Collagen type III, initially deposited in the area, is replaced by collagen type I, which has a tensile strength greater than its predecessor, culminating in the skin's firmer and more elastic nature (Gold, 2010).

Clinical Applications of Micro-Needling

Published evidence and anecdotal experience has demonstrated Micro-Needling is a safe and effective treatment option for a number of dermatologic issues both aesthetically and medically and may assist in :

Reducing the appearance of scars, including atrophic acne scars, hypertrophic scars, surgical scars, burn scars
Reducing the appearance of fine lines and wrinkles
Reducing enlarged pores by improving the dermal ECM structure surrounding each pore
Reducing the appearance of pigmentation disruption – melasma, hyperpigmentation and dark spots
Smoothing uneven skin tone and improving skin elasticity
Reducing the appearance of stretch marks and cellulite
Improving redness caused by rosacea by increasing blood circulation
Improving disrupted skin due to acne vulgaris
Promoting hair growth

Additionally, when Micro-Needling is paired with topical serums, it facilitates their absorption, bolstering their beneficial effects on the skin (Iriate,2017)

Raffine Micro-Needling Results

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Why Choose Raffine Micro-Needling for your patients

Safety

• ARTG listed & CE marked as medical devices: ARTG listed Handpiece 340668; ARTG listed Cartridges 352025

• Anti-contamination system complemented by needle and handpiece design

• Handpiece is ROHS compliant with 'ABS', exterior material, which is resistant to alcohol, and can be cleaned with alcohol or appropriate disinfectant.

Technology

• Mains powered for consistent and reliable power

• Precise adjustable needle depth (0.2 - 2mm)

• 4 speeds up to a maximum of 54,000 skin penetrations per minute

• Motor has low mechanical vibration and low noise - even at high speed

Design

• Exclusive to Raffine – patented design, 9-pin needle cartridges with dual locking mechanism.

• 33G medical grade stainless steel needles for precise needle penetration with minimal pain

• Ergonomic, lightweight, durable design

Price competitiveness

• Minimal investment for high quality, reliable technology

• High quality, affordable cartridges to maximise profit per procedure

• Training resources, theory course, marketing and protocols include in purchase

• 3-year warranty (excluding battery)

User Experience

• Smooth and consistent performance without drag

• Minimal noise and vibration due to an ideal match of motor to needle number, and design for motor drive shaft in a direct line

• Attention to ergonomic design with the centre of gravity weighted towards the skin improved the user experience and reduces operator fatigue.

• Excellent patient outcomes, and equivalent to equipment that has handpieces and cartridges for many multiples of Raffine pricing.

3-Year Warranty

• Due to Raffine’s product quality and longevity, Alocuro offers a 3-year warranty on all parts (with correct and safe usage of the device) in contrast to some competitor devices’ limited 1-year warranty period.

• This commitment to durability and customer satisfaction is indicative of Raffine's superior manufacturing quality.

Rigorous Quality Control

• Raffine upholds rigorous quality control standards to ensure that each needle tip aligns with the system's high-performance criteria.

• The quality inspection encompasses checks for the straightness of the micro-needles, the uniformity of needle length within a strict tolerance of +/- 5%, and the absence of any impurities on the needles.

• These standards aim to ensure a consistent treatment experience, minimise patient discomfort, maintain the integrity of the epidermis leading to high clinician confidence.

Registration as a Medical Device with the TGA

With its CE Medical certification and registration on the Australian Register of Therapeutic Goods (ARTG), this medical device technology meets rigorous safety and health standards, making it an efficacious choice for medical aesthetic Micro-Needling treatments

In Australia, a Micro-Needling device is subjected to requiring assessment and registration by the Therapeutic Goods Administration for inclusion on the Australian Register of Therapeutic Goods (ARTG), if the procedure makes a therapeutic claim such as:

claims to treat any skin condition, such as acne scarring, wrinkles, melasma and/or
claims to penetrate the skin.

The cartridges and handpiece are usually registered separately, and the needle cartridges are registered as a Class IIa medical device.

Alocuro Skin Devices’ Raffine Micro-Needling ARTG listings

• ARTG listed Handpiece 340668;

• ARTG listed Cartridges 352025

CE Marking Distinction

Raffine’s handpiece and 9-pin needle cartridges have received CE Marking as medical devices. This endorsement underscores the technology’s compliance with the European Union’s stringent health, safety, and environmental protection standards, affirming its superior quality in the competitive Micro-Needling market.