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Rainbow Thread PDO

Rainbow Thread PDO

Rainbow Thread

PDO thread lifting device
  • CE Marked medical device for thread Lift and skin Rejuvenation indications in accordance with European medical device regulations.
  • Manufactured by Oreon Life Science Co., Ltd., a Korean medical device company producing PDO Based thread Lift systems for international markets.
  • Distributed in the European Community (EC) through authorised wholesalers, complying with relevant import and distribution requirements.
  • Supplied sterile and single Use, in line with standard requirements for Class III implantable medical devices.
  • Intended for professional use only, with usage subject to local regulations governing minimally invasive aesthetic procedures.
PDO mono-type twin threads for facial tightening and rejuvenation

Description

Rainbow Thread PDO Twin 26G/38/60 is a polydioxanone (PDO) twin mono thread system designed for minimally invasive skin tightening, lifting and rejuvenation. Each device consists of a 26G x 38 mm needle preloaded with two intertwined PDO mono threads (twin configuration) of 60 mm length (USP 6-0). The twin design makes the overall thread thicker and stronger than a standard mono PDO thread, providing more efficient lifting and more intensive stimulation of collagen and elastin. The threads are fully biodegradable and are gradually resorbed by the body over 1–2 years while supporting tissue remodelling. They are supplied sterile in pouches and are intended for use by trained medical professionals for facial rejuvenation, wrinkle reduction and skin redensification.

Bnefits

  • Provides effective tightening and lifting of facial tissues with a minimally invasive thread-lift approach.
  • Twin configuration (two mono threads) offers stronger lifting power than standard single PDO mono threads.
  • Stimulates collagen and elastin formation for long-term improvement in skin firmness and elasticity.
  • Ideal for facial rejuvenation, wrinkle reduction and skin redensification.
  • Delivers immediate tissue-support and visible results, with further improvement over time.
  • Long-lasting effects, with clinical benefits that can persist for up to 2 years.
  • Threads are fully biodegradable PDO, which gradually dissolve and are replaced by newly formed connective tissue.
  • Can be used alone or combined with other aesthetic treatments such as dermal fillers, PRP or chemical peels.
  • CE-marked medical device produced by a specialist Korean manufacturer of thread-lift systems.
  • Packaged in high-count boxes, making it suitable and cost-effective for professional clinical use.

Indications

  • Non-surgical facial lifting and tightening using PDO thread-lift techniques.
  • Rejuvenation and redensification of sagging or lax facial skin.
  • Wrinkle reduction on the face, including fine to moderate static wrinkles and lines.
  • Improvement of skin texture and firmness in areas with reduced elasticity.
  • Adjunct to other aesthetic procedures (e.g. fillers, PRP, chemical peels) as part of combined anti-ageing protocols.
  • Use in thread-lift protocols for midface, jawline, cheeks and other appropriately selected facial areas at the clinician’s discretion.

Composition

  • Polydioxanone (PDO) absorbable suture material for the threads.
  • Stainless steel needle (26G) suitable for subdermal insertion of PDO threads.
  • Each thread: USP 6-0 PDO suture, length 60 mm, arranged as a twin mono configuration.
  • Each device: 26G x 38 mm needle carrying twin PDO mono threads.
  • Sterile packaging materials (pouches and box) appropriate for medical devices.

Formulation

  • Thread type: PDO Twin (two intertwined mono PDO threads).
  • Thread material: Polydioxanone (PDO), fully absorbable monofilament suture.
  • Gauge size: 26G needle.
  • Needle length: 38 mm.
  • Thread length: 60 mm PDO thread (USP 6-0).
  • Thread category: PDO mono-type twin thread for lifting and rejuvenation.
  • Configuration: Twin (double mono) for enhanced lifting strength and collagen stimulation.
  • Device classification: Sterile, single-use Class III medical device (PDO suture with needle), CE-marked.

Packaging

  • Pack content: 100 threads (5 pouches x 20 threads per pouch).
  • Each unit within the pouch: 26G x 38 mm needle preloaded with 60 mm PDO twin mono thread (USP 6-0).
  • Supplied in sterile pouches intended for single use only.
  • Pouches are packed into an outer cardboard box labelled with product name, gauge, thread/needle length, lot/batch number and expiry date.
  • Outer packaging includes manufacturer information (Oreon Life Science), CE mark and device symbols as required for medical devices.
  • Intended for professional clinical use; not for home or consumer self-treatment.

Usage

  • For professional use only: Rainbow Thread PDO Twin must only be used by appropriately trained and licensed medical professionals experienced in PDO thread-lift procedures and facial anatomy.
  • Before treatment, obtain a full medical history, assess the patient’s skin quality, degree of laxity, expectations, and suitability for PDO thread-lift, and obtain informed consent.
  • Inspect the packaging to ensure sterility and integrity; do not use if the pouch is damaged, opened or past the expiry date.
  • Mark the intended insertion and exit points and vectors on cleansed skin according to the planned thread-lift design for the patient.
  • Prepare the treatment area with appropriate antiseptic solution and maintain strict aseptic technique throughout the procedure.
  • Administer local anaesthesia (e.g. lidocaine with or without adrenaline) as required at planned entry and, if needed, exit points in accordance with local protocols.
  • Insert the 26G x 38 mm needle carrying the twin PDO thread into the subdermal plane along the predetermined vector, using smooth, controlled movements, avoiding superficial placement or entry into blood vessels.
  • Advance the needle to the desired endpoint, then withdraw the needle while leaving the twin PDO threads in place, ensuring that the thread is correctly anchored within the tissue.
  • Repeat placement of additional threads as needed to achieve the desired lifting and tightening effect, following manufacturer and protocol guidance on maximum number and spacing of threads.
  • Gently compress and smooth the treated area with gloved fingers to adapt tissues to the new vector and to reduce any irregularities or dimpling; trim any external thread remnants if present.
  • Provide aftercare instructions to the patient: avoid strong facial movements, massage of the treated area, strenuous exercise, sauna/steam rooms and dental treatment involving wide opening of the mouth for a specified period (commonly 1–2 weeks, according to clinic protocol).
  • Advise the patient about common temporary effects such as mild swelling, bruising, tenderness or a feeling of tightness, and instruct them to seek immediate medical attention if they experience severe pain, marked asymmetry, signs of infection, or any unusual symptoms.
  • Schedule a follow-up visit to review results, monitor healing and manage any complications or adjustments if necessary.
  • Dispose of used needles and remaining materials in approved sharps and clinical waste containers according to local regulations; the device is single-use and must not be resterilised or reused.

Contraindications

  • Known hypersensitivity or allergy to polydioxanone (PDO) or any component of the device.
  • Active infection, inflammation, or skin disease in or near the intended treatment area (e.g. cellulitis, active acne, herpetic lesions).
  • Severe or uncontrolled systemic illness, including uncontrolled diabetes or coagulation disorders, where wound healing may be impaired.
  • Patients with bleeding disorders or on significant anticoagulant or antiplatelet therapy, where the risk of bleeding or bruising is considered unacceptable (subject to clinician judgement).
  • History of keloid or hypertrophic scar formation, where insertion of threads may increase risk of abnormal scarring.
  • Autoimmune or connective tissue diseases where foreign-body response may be unpredictable, unless carefully evaluated and deemed acceptable by the treating physician.
  • Pregnancy and breastfeeding, as safety data for thread-lift procedures are lacking and treatment is generally not recommended.
  • Known tendency to poor wound healing or severe allergic reactions.
  • Patients with unrealistic expectations or contraindications identified during medical assessment.
  • Use in anatomical areas that are not recommended by the manufacturer or beyond the competence of the treating practitioner.

Adverse Effects

  • Common, usually mild and transient effects at the insertion sites such as redness, swelling, bruising, tenderness or soreness.
  • Temporary dimpling, rippling or irregularity of the skin surface along the thread path, which typically settles as tissues adapt.
  • Haematoma or local bleeding at needle insertion points.
  • Infection at the thread entry or along the thread path, potentially requiring antibiotics or, in rare cases, thread removal.
  • Asymmetry or suboptimal aesthetic outcome if thread placement or tension is not balanced.
  • Palpable or visible threads, nodules or irregularities if threads are placed too superficially or unevenly.
  • Thread migration, breakage or extrusion through the skin in rare cases, possibly requiring correction or removal.
  • Localised inflammatory or foreign-body reaction around the PDO threads, very rarely granuloma formation.
  • Nerve irritation or injury, causing transient pain, altered sensation or, rarely, persistent sensory changes, depending on anatomical site.
  • Vascular injury (including vessel puncture) with associated bleeding, haematoma or, in extremely rare circumstances, tissue ischaemia or necrosis if vascular compromise is severe.
  • Any severe, persistent or unexpected adverse reaction should prompt immediate clinical review and appropriate management.

Storage Conditions

  • Store in a clean, dry place at normal room temperature within the range specified on the packaging (typically controlled room temperature).
  • Protect from excessive heat, moisture and direct sunlight.
  • Keep the product in its original packaging until use to maintain sterility and protect it from physical damage.
  • Do not use after the expiry date indicated on the box and pouches.
  • Do not use if the sterile barrier is damaged, opened or compromised.
  • Store out of reach of unauthorised persons and children.
  • Single-use sterile product: once a pouch is opened, use immediately and discard any unused devices from that pouch if sterility is in doubt.

Duration

Rainbow Thread PDO Twin provides immediate lifting and tightening, with full collagen-stimulating effects developing over weeks to months. Results typically last up to around 2 years, with the PDO threads themselves fully biodegrading and dissolving within approximately 1 to 2 years. Actual duration depends on factors such as patient age, skin quality, degree of laxity, lifestyle and the number and placement of threads used.

Onset

Immediate tissue support and visible tightening or lifting are usually observed right after insertion of the threads, with progressive improvement over subsequent weeks as collagen and elastin production is stimulated and tissue remodelling occurs.

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