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TEOSYAL® PureSense Deep Lines (2 x 1 ml)

TEOSYAL® PureSense Deep Lines (2 x 1 ml)

Teosyal

Medical device — hyaluronic acid dermal filler
  • CE marking for TEOSYAL PureSense product family indicated in manufacturer IFU and product literature.
  • Manufactured by TEOXANE Laboratories SA under applicable quality standards (IFU references and company ISO/quality systems in product literature).
  • Traceability labels included in pack (one for patient record and one for clinician records) as part of regulatory/compliance practice.
Cross-linked HA dermal filler for deep wrinkles / mid-deep dermal augmentation

Description

TEOSYAL® PureSense Deep Lines is a sterile, single-use, cross-linked hyaluronic acid gel (non-animal origin) containing lidocaine, manufactured by TEOXANE Laboratories. It is formulated with rheological properties adapted for filling deep wrinkles and creases and restoring facial contour. The product is supplied as two 1 ml pre-filled syringes per pack and is intended for injection into the mid-to-deep dermal layer for correction of pronounced wrinkles (e.g., severe nasolabial folds, marionette lines) and facial contour augmentation.

Bnefits

  • Optimised viscoelastic profile for in-depth filling of pronounced wrinkles and folds
  • Contains lidocaine (0.3%) to improve injection comfort
  • Immediate visible correction of deep lines and folds after injection
  • Non-animal origin, cross-linked hyaluronic acid gel with manufacturing controls (TEOXANE PureSense range)
  • CE-marked product family with traceability labels included in the pack (two 1 ml syringes per pack)

Indications

  • Treatment of deep facial wrinkles and creases (e.g., severe nasolabial folds, marionette lines)
  • Cheek augmentation and restoration of facial shape/contour where mid-to-deep dermal or subcutaneous placement is clinically indicated
  • Lip augmentation and other deep-line volumising procedures when clinically appropriate (practitioner discretion)

Composition

  • Cross-linked hyaluronic acid (non-animal origin) — commonly listed at 25 mg/ml for Deep Lines in product listings and reseller/spec pages
  • Lidocaine (0.3% w/v; 3 mg/ml) as local anaesthetic included in the gel
  • Cross-linking and rheological properties per TEOXANE PureSense manufacturing process (proprietary HCCL/production controls described by manufacturer)

Formulation

  • Sterile, injectable, monophasic cross-linked hyaluronic acid gel with lidocaine (0.3%)
  • Provided as pre-filled sterile syringes (2 x 1 ml per pack) with needles/traceability labels included as per regional pack configuration
  • Designed for mid-to-deep dermal injection using recommended needle/cannula sizes

Packaging

  • Pack contains 2 x 1.0 ml pre-filled sterile syringes (traceability labels included).
  • Each syringe supplied in sterile single-use packaging with needles included in many regional packs (confirm pack contents on local distributor labelling).

Usage

  • For professional use only by qualified and trained healthcare practitioners experienced in injectable dermal fillers.
  • Inject into the mid-to-deep dermal layer (depth and technique per practitioner judgment and IFU).
  • Follow aseptic technique; ensure skin preparation agents are dry before injection.
  • Observe recommended injection techniques, needle/cannula selection and volumes per the TEOXANE instructions for use and local clinical protocols.
  • Monitor the patient for immediate complications for at least 30 minutes post-procedure as recommended in patient leaflets.
  • Advise patients about aftercare: avoid make-up for 12 hours, avoid alcohol and excessive sun/UV exposure for 1 week, and avoid dental/aesthetic procedures for 15 days as noted in manufacturer guidance.

Contraindications

  • Known hypersensitivity to hyaluronic acid or lidocaine (local anaesthetics of the amide type).
  • Active infection or inflammation at the intended injection site (do not inject into infected or inflamed skin).
  • Pregnancy and lactation (manufacturer advises to refrain from treatment if pregnant or breastfeeding).
  • Patients with severe allergic reactions (history of anaphylaxis) or known severe allergies.
  • Use caution or avoid in areas previously treated with other fillers unless interactions have been considered; do not inject where other implants are present without specialist assessment.

Adverse Effects

  • Common/very common (most often temporary): redness, bruising, haematoma, bumps, oedema, erythema, itching, pain, temporary loss of sensation, dyschromia at the injection site.
  • Delayed or persistent reactions: swelling or nodules that may appear later at the injection site; consult a practitioner if these occur.
  • Rare but serious: abscess, granuloma, immediate hypersensitivity (including anaphylactic shock), vascular complications potentially leading to necrosis, visual disturbances or blindness (practitioners must be prepared to recognise and manage these rare events).
  • Practitioner-recommended post-injection monitoring of at least 30 minutes to detect immediate serious incidents.

Storage Conditions

  • Store between 2 °C and 25 °C (refrigerated or room temperature storage allowed within this range), away from direct sunlight as specified in product IFU.
  • Keep in original packaging until use and check packaging integrity and expiry date before administration.

Duration

Estimated in vivo lifetime reported in manufacturer literature and patient IFU for TEOSYAL PureSense Deep Lines: 12 to 18 months (clinical duration depends on patient factors and treatment specifics).

Onset

Immediate visible volumising/correction upon injection (manufacturer and reseller product pages report immediate effect); full settling may be observed over subsequent days.

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