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Medical Mandatory Statements

Medical Devices 

The Emsella® Chair is a non-invasive, TGA- and FDA-cleared treatment for urinary incontinence and pelvic floor strengthening. While clinical studies support its efficacy, individual results may vary. This treatment may not be suitable for everyone. It is not recommended for individuals with metal implants, pacemakers, or during pregnancy.

All clients must undergo a consultation with a qualified practitioner to determine suitability. Please consult with your healthcare provider if you have underlying medical concerns.

DermaPen device and cartridge are Class IIa medical devices for electronic cosmetic micro-needling. To stimulate tissue regeneration and improve the appearance of the skin (to treat acne scarring, fine lines, wrinkles and patchy or irregular skin discolouration. All medicines, medical devices and treatments carry benefits and risks. Individual results may vary.

Speak to your qualified Clinician to determine if micro-needling is right for you.

Always follow the aftercare instructions you have been given.

Derma Pen IP Holdings, LLC is the registered owner of the DERMAPEN® Mark and with F.D. Holdings

Ultraformer III HIFU (High-Intensity Focused Ultrasound) is a non-invasive treatment designed for skin lifting, tightening, and body contouring. Individual results may vary. This treatment is not suitable for everyone. A thorough consultation and assessment by a qualified practitioner are required to determine suitability. Ultraformer III is not intended to diagnose, treat, cure, or prevent any medical condition. Contraindications may include pregnancy, active skin infections, severe acne, open wounds, or certain medical conditions. Always consult your healthcare provider before undergoing any aesthetic treatment.


Injectables 

XEOMIN® (Incobotulinumtoxin A) 50, 100 Units is a Prescription Medicine. Indications: In adults, for the treatment of cervical dystonia; blepharospasm; spasticity of the upper limb; upper facial lines: glabellar frown lines, lateral periorbital lines (crow's feet), horizontal forehead lines. XEOMIN® has both risks and benefits, consult your clinician to understand if XEOMIN® is right for you. Individual results may vary. Further information on the risks and benefits of XEOMIN® can be
found in the Consumer Medicine Information (CMI) available from www.medsafe.govt.nz or by calling 0800 822 310. Use strictly as directed. Always follow the advice of your healthcare professional / clinician in terms of treatment aftercare. If symptoms continue or you have side effects, see your health care professional.

Common side effects include: Headaches; nausea; tenderness, swelling, redness, numbness or bruising of the skin; dry eye; heavy feeling of eyelid/eyebrow/forehead; face/brow not symmetrical, dropping eyelids/eyebrows. Serious side effects are rare and include allergic reactions.

XEOMIN® is an unfunded medicine, Charges will apply.

Medical information: Ph: 0800 822 310. Copyright@ 2023. Pharmacy Retailing NZ Limited +/a Health Care Logistics (HCL) 58 Richard Pearse Drive, Mangere, Auckland
2022. All rights reserved. XEOMIN® and Merz Aesthetics are registered trademarks of Merz Pharma GMbH & Co. KGaA.

ASK YOUR HEALTH CARE PROFESSIONAL IF XEOMIN® IS RIGHT FOR YOU.


Belotero® is a Class III medical device to smooth facial wrinkles and folds, correct facial atrophic scars, restore of enhance the lips or restore facial volume

Belotero has risk and benefits. Ask your specialist if Belotero is right for you.

Contains transparent cross-linked sodium hyaluronate gel of nonanimal origin with lidocaine 0.3% to reduce local pain.

Do not use if you have a skin inflammation or a skin infection or until the infection is healed.

Precautions. There is a risk of infection. Tell your doctor if you are on blood-clotting medicines as there could be an increased risk of bruising or bleeding at the injection site.

Possible side effects: swelling, bruising, redness hardening of the skin, pain, altered colour or itching.

Lasts 6-12 months

You will need to pay for this product and doctor’s fees apply.

Merz, Sydney. Distributed by Healthcare Logistics, Auckland


SUNEKOS 

Sunekos 1200 is an implantable medical device that modifies the structure of mature skin, restoring volume, filling wrinkles and folds in the skin and in scar sites. It is suitable for creating a temporary increase in the volume of skin tissue. Sunekos 1200 is a medical device that is sterile, injectable, non-pyrogenic, biocompatible, re-absorbable, made with hyaluronic acid and amino acids.

Sunekos Performa is a medical device recommended for the treatment of blemishes and depressions in the skin caused by wrinkles and scars. Sunekos Performa is a sterile resorbable injectable solution which acts as a filler, supporting the restoration of physiological elasticity and temporarily replacing volume by expanding the soft tissues.

Sunekos should not be used on patients: with known hypersensitivity to any of its components; presenting with a general infection, inflammatory or infectious cutaneous problems; with history of severe multiple allergies or anaphylactic shock; prone to hypertrophic scars/keloids or streptococcal diseases; in patients presenting with porphyria; under 18 years of age; in pregnancy or lactation; others. See full Instructions for use before prescribing for full safety information, available from www.xytide.co.nz

Copyright© 2024. Xytide Biotech Pty Ltd. Always read the label and follow the instructions. This medical device must be administered by a Healthcare Professional. New Zealand

Sponsor: AA-Med Pty Ltd Distributed by: Xytide Biotech NZ Pty Ltd (NZBN 9429049668612) C/O Alliott Ltd, Level 2, 142 Broadway, Newmarket, Auckland 1023 NZ. For more information please phone +61 1800 570 036

 

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