Why TGA Approval Matters When Buying an LED Face Mask in Australia

Our brand is currently operating within Australia for now. However, shipping to other countries will need to arranged as a 'special order' and will incur additional costs.

It depends on where you are. Orders processed here will take 5-7 business days to arrive, or potentially sooner if Express Post has been selected upon check-out. Delivery details will be provided in your confirmation email.

You can contact us through our contact page or email us directly! We will be happy to assist you.

email: info@souleir.com

Delivery:

We offer free standard delivery across Australia and free Express delivery for orders over $500.

Order Tracking:

Tracking details are emailed once orders leave our Gold Coast location.

Returns & Guarantee:

We provide a 14-day change-of-mind period for unused items. Opened devices are covered by a 60-day results-based guarantee after a 21-day trial.

Warranties & Defects:

Souleir products include a warranty, and in case of a manufacturing defect, please refer to the returns and satisfactory guarantee terms and conditions.

Souleir prioritises the health and safety of our customers above all else.

Below are the certifications that our manufactures have attained and are bound by.

TGA Approved

TGA approved means that a product has been assessed and approved by the Therapeutic Goods Administration (TGA), which is Australia's regulatory authority for medical and therapeutic products. This approval ensures that the product meets strict safety, quality, and efficacy standards before being marketed or sold in Australia.

For medical devices, TGA approval confirms that the product complies with the Medical Device Regulations and is registered on the Australian Register of Therapeutic Goods (ARTG).

International Standards

• IEC 60335-1:2010 + AMD1:2013 + AMD2:2016
• IEC 60335-2-115:2021

Australia & New Zealand Standards

• AS/NZS 60335.1:2020+A1:2021
• AS/NZS 60335.2.115:2021+A1:2022

These certifications ensure our products meet rigorous international safety standards for electrical appliances and beauty care devices.

MDSAP

Medical Device Single Audit Program - A program that allows a single regulatory audit of a medical device manufacturer to satisfy multiple regulatory requirements. This means our product meets quality standards across multiple countries.

ISO13485

A quality management standard specifically for medical devices. This certification ensures our products are consistently manufactured under strict quality control processes that meet international safety standards.

FDA

Food and Drug Administration - The U.S. government agency responsible for protecting public health by regulating medical devices, drugs, and food products. FDA certification means our product meets U.S. safety standards.

FCC

Federal Communications Commission - A U.S. certification that ensures electronic devices meet standards for electromagnetic interference. This means our device won't interfere with other electronic equipment.

RoHS

Restriction of Hazardous Substances - A certification that confirms our product is manufactured without specific hazardous materials like lead, mercury, and certain flame retardants. This makes our product safer for both you and the environment.

SAA

Standards Association of Australia - An Australian certification mark that indicates our product meets their national safety and quality standards.

Oeko-Tex® Certification

Our mulberry silk products are Oeko-Tex® certified, meaning they are tested for harmful substances and safe for human use.

This globally recognised standard ensures quality, safety, and eco-friendly production practices, giving you peace of mind with every purchase.

CE Conformité Européenne

A certification mark indicating our product meets the European Union's health, safety, and environmental protection standards. It allows our products to be sold within the European market.

Yes. The Souleir Skin Restore Mask has been EMF tested and recorded a reading of 0.7 milligauss (mG) - less than 1% of the 2,000 mG public safety limit set by ARPANSA, Australia's radiation protection authority.

Yes. Souleir's technology has been clinically proven to produce medical-grade results. Souleir's devices have been specifically tested in clinical studies, with applications ranging from skin rejuvenation, acne, pigmentation, and other common skin conditions.

Please note: Not all LED masks are created to produce quality results!

Some brands lack the clinical studies or TGA/FDA/ISO clearance that demonstrate proven effectiveness.

A slight pinkish flush immediately after an LED light therapy session is completely normal and nothing to be concerned about.

It's a sign of increased blood circulation in the treated area - your skin responding to the therapy exactly as it should.

This post-session glow typically fades within a few minutes to an hour.

Because an irradiance of 30-35mW/cm² is standard for phototherapy, true adverse reactions are rare; however, if your skin is prone to extreme sensitivity and sudden irritation, we highly recommend consulting a qualified dermatologist to assess your skin's overall compatibility with LED light treatments before purchasing and using any such devices.

• Reduces fine lines and wrinkles: Achieve smoother, younger-looking skin
• Boosts collagen production: Firm and plump your skin for a radiant glow.
• Alleviate Skin Conditions: Effective against rosacea, psoriasis, eczema, acne, and pigmentation.
• Natural, no pain, side effects or downtime
• Incorporated into any skincare routine

Yes, we do! Please visit our Clinical Bibliography here.

The Souleir LED therapy devices are intended only for the uses listed in its product indications. It has not been tested for any other conditions, and potential risks for unapproved use are unknown.

You can expect to see visible results in just 4 weeks when used consistently 10-20 minutes a day, 3 to 5 times per week.

We recommend using the LED mask on clean, product free skin, to avoid blockage of LED light from entering the skin.

LED therapy is generally considered safe for most people, as it is non-invasive and does not emit harmful UV rays. However, there is limited research on its use during pregnancy, so it is often recommended to err on the side of caution.

If you are pregnant, it’s best to consult with your healthcare provider before using LED therapy to ensure it is safe for you and your baby.

Additionally, avoid using LED devices on the abdominal area during pregnancy unless advised by a medical professional.

Yes, it is possible to overdose on light.

Red light therapy follows a biphasic dose-response, where too little light has minimal effect, the optimal dose provides maximum benefits, and excessive light diminishes the positive effects.

To avoid overdosing, adhere to the recommended guidelines.

Monitor your individual response and adjust your session duration as needed.

Everyone's sensitivity to light varies, so it's important to find the balance that works best for you.

We generally do not recommend combining retinol with any form of light therapy, as there is always a risk of reaction.

While some individuals do use both products concurrently with no adverse reaction, transparency regarding potential effects is paramount to us. We always suggest using serums and moisturisers after your LED treatment to minise any risk of irritation.

We strongly advise consulting with your dermatologist or provider, who can give you personalised guidance based on your skin's unique needs.

Yes. During perimenopause, declining oestrogen accelerates collagen loss and skin thinning.

Red light therapy clinically stimulates collagen production and improves skin density, making it one of the most effective at-home tools for hormonally changing skin.

Salon LED treatments can cost $80–$150 per session.

Souleir's TGA-approved device delivers medical-grade wavelengths from home, with no booking, no travel and no ongoing cost.

We offer nothing but the best for our clients...

• 6a Grade is finest quality raw silk, with long strands, minimal defects, and a natural shine
• 900 thread count means a finer weave + smoother feel
• 22 momme is considered a high-quality weight for silk - the perfect thickness and durability for products such as pillowcases, sheets + sleep masks.

For best results, hand wash in cool water using a pH-neutral detergent and fabric softener. Since silk is a natural fiber, avoid rubbing the fabric vigorously or wringing it out forcefully.

To prevent fading, we recommend air drying in the shade.

Following these care instructions will help extend the longevity of your purchase.

Silk is hypoallergenic, non-irritating, and can help with frizz, tangles, and hair breakage.

It's also a good choice for people who sleep hot or cold as it naturally regulates temperature.

Mulberry silk sleep masks can have many benefits for your skin and sleep, including being hypoallergenic, hydrating, and antimicrobial.

Skin benefits

• Anti-aging: 
  Mulberry silk can promote a smoother complexion and reduce the appearance of fine lines and wrinkles 
• Reduces puffiness, dark circles around the eye area
• Hydrating: 
  Mulberry silk helps retain moisture and keeps skin healthy 
• Hypoallergenic: 
  Mulberry silk is a good choice for people with sensitive skin or allergies 
• Antimicrobial: 
  Mulberry silk can help protect against bacteria 
• Reduces dark spots: 
  The antioxidants in mulberries can help fade skin blemishes 

Sleep benefits

• Helps you fall asleep: 
  A silk sleep mask can help you fall asleep more easily
• Prevents exposure to harmful light: 
  A silk sleep mask can block out harmful light
• Improves sleep quality: 
  A silk sleep mask can help you relax and sleep more soundly

Other benefits

• Mulberry silk is naturally hypoallergenic 
• Mulberry silk has less friction than cotton, which can help reduce creases and prevent wrinkles 
• Mulberry silk is hydrophobic, which means it sheds water instead of absorbing it 

Silk bedding is often recommended for individuals with allergies and sensitive skin due to its naturally hypoallergenic properties.

Gentle and non-irritating, silk is suitable for even the most delicate skin types, including babies. It provides an ideal sleeping surface for those with acne-prone skin, eczema, psoriasis, or other skin conditions.

Additionally, silk naturally resists mold, fungus, and dust mites - common household allergens - offering a cleaner and more comfortable sleep environment.

Absolutely. Natural mulberry silk is an excellent choice for those who sleep either hot or cold.

Yes. Silk's hollow-core fibre structure naturally regulates temperature and wicks moisture without retaining dampness — keeping you cool and dry. Ideal for women experiencing night sweats during perimenopause or menopause, and comfortable year-round for all sleep types.

A silk pillowcase cannot stop androgenetic (genetic) hair loss, but it significantly reduces mechanical hair damage - breakage, split ends, and traction stress - that occurs during sleep.

Lab testing shows silk reduces hair friction by 34% compared to cotton.

For men using Minoxidil or recovering from a hair transplant, silk is an essential protective surface that supports your other treatments.

Yes. After a hair transplant, new grafts are extremely fragile for the first 10–14 days. Sleeping on a rough cotton surface can dislodge or damage grafts.

A 6A-Grade mulberry silk pillowcase provides the gentlest possible surface, minimising friction and pressure on the scalp during this critical recovery period.

Many hair transplant surgeons recommend silk pillowcases as part of post-operative care.

Cotton pillowcases are highly absorbent and can draw topical treatments like Minoxidil away from your scalp during sleep.

Silk is far less absorbent, meaning more of your treatment stays where it belongs — on your scalp — maximising its effectiveness.

This makes silk an important complement to any topical hair loss treatment.