Class III CE Marked medical device based on highly purified polynucleotides (PDRN/PN HPT®) for intradermal injection in the periocular area.
Manufactured by Mastelli S.r.l. under a medical device quality management system compliant with European regulatory requirements (e.g. ISO 13485).
Class III CE Marked medical device based on highly purified polynucleotides (PDRN/PN HPT®) for intradermal injection in the periocular area.
Manufactured by Mastelli S.r.l. under a medical device quality management system compliant with European regulatory requirements (e.g. ISO 13485).
Periocular polynucleotide injectable gel
Description
Plinest Eye (1 x 2ml Syringe) is a polynucleotide (PDRN/PN-HPT®) skin booster specifically formulated for the delicate periocular and under-eye area. The sterile injectable gel, supplied in a 2 ml pre-filled syringe, is designed to improve periocular skin texture by providing deep hydration, reducing puffiness, brightening dark circles and softening fine lines. By delivering highly purified polydesoxyribonucleotide at 7.5 mg/ml, it stimulates fibroblast activity, supports collagen production and enhances tissue regeneration, resulting in firmer, smoother and more radiant skin around the eyes.
Bnefits
Explicitly formulated for the delicate under-eye and periocular area.
PDRN/PNCs address puffiness, dark circles and fine lines in the under-eye zone.
Provides deep moisture to plump and smooth the periocular skin.
Stimulates fibroblast activity and collagen production for a firmer, more youthful appearance.
Improves periocular skin texture, elasticity and overall skin quality.
Brightens the under-eye area to reduce the appearance of dark circles and signs of fatigue.
Non-volumising biostimulator focused on skin regeneration and quality rather than bulk filling.
Supplied ready to use in a 2 ml pre-filled syringe for precise intradermal injection by trained professionals.
Indications
Improvement of periocular skin texture and quality.
Treatment of fine lines and superficial wrinkles around the eyes.
Reduction of under-eye puffiness and bags.
Brightening of dark circles in the under-eye area.
Hydration and firming of thin, delicate periocular skin.
Composition
Polydesoxyribonucleotide (PDRN): 7.5 mg/ml (15 mg total in 2 ml).
Sterile, apyrogenic aqueous gel carrier solution (other excipients not fully specified in public technical data).
Highly purified polynucleotides derived from fish DNA intended for human consumption, purified to remove proteins and other potentially immunogenic components.
1 x 2 ml pre-filled syringe of Plinest Eye gel per pack.
Typically supplied with 2 x 30G 1/2" disposable sterile needles (as stated by multiple distributors).
Single-use, sterile blister and outer carton labelled for professional medical use only.
Usage
For use only by suitably trained and licensed healthcare professionals experienced in injectable aesthetic procedures.
Cleanse and disinfect the periocular treatment area according to standard aseptic protocols.
Inject Plinest Eye intradermally in small aliquots into the delicate under-eye/periocular area, using micro-papular, serial puncture or linear retrograde threading techniques as recommended in Plinest Eye protocols.
Avoid intravascular injection and respect anatomical danger zones around the eye; aspirate according to clinic policy where appropriate.
Typical treatment plans involve a course of several sessions (commonly 3–4) spaced about 2–3 weeks apart, with exact regimen tailored by the clinician to patient needs and skin condition.
After injection, gentle massage of the treated area may be performed if indicated to help distribute the product evenly.
Provide standard post-treatment advice: avoid makeup on treated areas for several hours, minimise sun/heat exposure, avoid strenuous exercise immediately post-treatment, and follow any additional clinic-specific aftercare instructions.
Dispose of the used syringe, needles and any residual product immediately after treatment in approved sharps and clinical waste containers; do not reuse or resterilise.
Contraindications
Known hypersensitivity or allergy to fish-derived products, polynucleotides (PDRN) or any component of the formulation.
Active skin infection, inflammation, dermatitis or other dermatological disease at or near the intended injection site.
Severe systemic illnesses, uncontrolled autoimmune diseases or coagulation disorders where injectable aesthetic procedures are contraindicated unless risk–benefit has been carefully evaluated.
History of severe hypertrophic scarring or keloid formation in or near the periocular region.
Pregnancy or breastfeeding, and patients under 18 years of age, due to insufficient safety data.
Use by non-medical personnel or any form of self-injection is contraindicated.
Adverse Effects
Common injection-related reactions such as transient redness, swelling, tenderness, bruising or mild pain at injection sites.
Temporary papules or small lumps at injection points, which usually resolve spontaneously within a few days.
Occasional itching, warmth or mild discomfort in the treated area.
As with other intradermal injectables, there is a risk of infection, prolonged inflammation or rare granulomatous reactions, which may require medical management.
Very rare but serious complications associated with intradermal injections, such as vascular compromise or tissue necrosis, may occur if product is inadvertently injected intravascularly or if incorrect technique is used.
Storage Conditions
Store in a cool, dry place away from direct sunlight, within the temperature range specified on the packaging (typically controlled room temperature).
Do not freeze and protect from excessive heat or sudden temperature fluctuations.
Keep the pre-filled syringe in its original carton until use to maintain sterility and protect from light and contamination.
Do not use after the expiry date or if the packaging, syringe or sterility seal is damaged.
Duration
Clinical and distributor information indicate that results typically develop over a course of 3\u20134 sessions and can last approximately 4\u20136 months in the periocular area, after which maintenance treatments may be performed according to individual patient needs and practitioner recommendations.
Onset
Initial improvements in hydration and smoothness of the under-eye skin may be noticeable within days to a few weeks after treatment initiation, with more pronounced benefits in texture, brightness and fine-line reduction developing progressively over several weeks and sessions as dermal regeneration and collagen synthesis occur.
