What “TGA approved” really means for red light devices in Australia (ARTG vs FDA cleared)

If you’ve searched “red light therapy TGA approved” or “red light therapy mask TGA approved”, you’ve probably seen plenty of confident marketing. The trouble is, “TGA approved” isn’t a label the Therapeutic Goods Administration (TGA) allows on therapeutic goods advertising, and it doesn’t mean what most people think it means.[1]

This page is general information only. It isn’t medical or legal advice. For advice about your own health, please check with your GP or another qualified health professional.

ARTG included vs “TGA approved” vs FDA cleared (510k)

ARTG included. The Australian Register of Therapeutic Goods (ARTG) is the TGA’s public register of therapeutic goods that can be lawfully supplied in Australia.[2][3] When a sponsor (the person or company legally responsible for supplying the product here) applies and meets the regulatory requirements, the product is “included in the ARTG”. The TGA describes this as market authorisation, meaning permission to supply.[2] Higher risk goods are assessed against requirements for quality, safety and, where appropriate, performance. Applications for some lower risk goods are validated rather than fully assessed.[2][4]

“TGA approved”. This is a marketing phrase, not a regulatory status. The TGA states that inclusion in the ARTG “is not an endorsement” of a product. Advertisers must not use terms like “TGA approved”, “TGA registered” or “TGA endorsed”, or use a TGA logo or the Commonwealth Coat of Arms.[1] Australia’s Therapeutic Goods Advertising Code also says advertising must not suggest that a government or government authority has endorsed the goods.[5] What advertisers can do is quote the ARTG number, for example “Product X is entered in the ARTG, ARTG 123456”, so you can look it up yourself.[1] So if you’re hunting for “TGA approved red light therapy devices”, the more useful thing to look for is an ARTG number.

FDA cleared (510k). This is a United States term. A 510(k) is a premarket submission showing that a device is “substantially equivalent” to a device already legally on the US market. If the FDA agrees, it issues an order that “clears” the device for sale in the US.[12] That’s different from FDA premarket approval (PMA), the FDA’s most stringent pathway, which is used for higher risk (Class III) devices and needs sufficient valid scientific evidence that the device is safe and effective for its intended use.[13] When you see “red light therapy FDA cleared”, it usually refers to a 510(k) clearance, not an approval. Searches for “FDA approved at home red light” often mix the two terms up. ‘FDA approved’ is a United States term. An FDA decision doesn’t put a product on the ARTG, so it isn’t a substitute for checking the ARTG yourself.[3]

How to check a device’s ARTG number on the public register

You can check an ARTG entry for free in a few minutes:

1. Ask for the ARTG number. Ask the seller for the device’s ARTG ID. A compliant advertisement may already show it.[1]
2. Open the ARTG search. Go to the TGA website and search the ARTG. The TGA also offers a more detailed search tool built for larger screens and the Chrome browser.[3][4]
3. Search by number or name. Enter the ARTG ID. You can also search by product name, sponsor name or other details.[3][4]
4. Check the sponsor. Make sure the sponsor named in the entry matches the company you’re buying from, or the company it says it supplies through.
5. Check it’s the same kind of device. Device entries often don’t record the trade (brand) name.[4] Instead, compare the device type and description with what you’re actually buying. A wall panel, a mask and a belt are different products.
6. Read the intended purpose. Open the entry or its Public Summary document and read what the device is intended to be used for.[4]
7. Check it’s current. The standard search shows active entries.[4] If you can’t find a number, it may have been cancelled, so check the TGA’s cancellation datasets too.[10]

Ask the same questions whether you’re looking for a red light therapy belt that’s “TGA approved” or a full-body panel.

What a device’s intended purpose limits it to

Every medical device on the ARTG has an intended purpose, which is what the sponsor says the device is for. Advertising must match that purpose. Promoting a medical device for a purpose that isn’t accepted in its ARTG entry is an offence under the Therapeutic Goods Act 1989.[5][6] Even ads aimed only at health professionals must stay within the intended purpose.[6]

In practice, an ARTG entry covers what’s written in it, and nothing more. When a product’s marketing promises far more than its ARTG entry describes, treat that as a red flag.

Why wellness-only devices aren’t regulated by the TGA

The TGA regulates therapeutic goods. In broad terms, a product is a medical device when it’s intended to diagnose, prevent, monitor, treat or alleviate a disease or injury, or to modify or monitor the body’s anatomy or physiological functions.[5] Whether a product counts as a therapeutic good depends on how it’s presented, including the claims made about it.[7]

The TGA told ABC News that red light products are regulated as medical devices when they’re intended for a therapeutic purpose. Its example was a red light mask claimed to treat severe acne. Products promoted only for cosmetic or wellbeing purposes, without therapeutic claims, are not regulated as medical devices.[8]

So many red light products are legitimately not on the ARTG. Not being on the ARTG doesn’t automatically mean a device is unsafe, and being on it doesn’t mean a product “works” for whatever its ads claim. Separately, the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) notes that, unlike some lasers and IPL devices, LED phototherapy used for cosmetic purposes isn’t subject to specific regulation in Australia. It advises consumers to follow instructions and protect their eyes.[9]

Can an ARTG listing be cancelled?

Yes. ARTG entries can be cancelled. The TGA can cancel an entry after a review, and sponsors can ask for their own entries to be cancelled, for example when they stop supplying a product. The TGA publishes these cancellations.[10][11] Once an entry is cancelled, the sponsor can no longer import, export or manufacture the product under it unless an exemption applies.[10]

Red light devices are no exception. The TGA’s public records show a red/infrared light phototherapy unit whose ARTG entry was cancelled at the sponsor’s request, effective 30 June 2026.[11] A sponsor-requested cancellation isn’t necessarily a sign of a problem with the device. It does show why an ARTG number quoted on an old webpage or box is worth re-checking today.

FAQ

How do “ARTG included”, “TGA approved” and “FDA cleared (510k)” differ? “ARTG included” means a product has market authorisation to be supplied in Australia.[2] “TGA approved” is a phrase advertisers aren’t allowed to use, because ARTG inclusion isn’t a TGA endorsement.[1] “FDA cleared” means the US FDA found a device substantially equivalent to one already on the US market. That’s different from FDA approval, and it doesn’t put a device on the ARTG.[12][13]

How do I check a device’s ARTG number on the public register? Get the ARTG ID from the seller, search it on the TGA’s ARTG search, then check the sponsor, device type, intended purpose and that the entry is current.[3][4]

What does a device’s intended purpose limit it to? It limits how the device can lawfully be advertised. Advertising a medical device for a purpose not accepted in its ARTG entry is an offence.[5][6]

Why are wellness-only devices not regulated by the TGA? The TGA regulates goods presented for therapeutic purposes. Red light products promoted only for cosmetic or wellbeing purposes, without therapeutic claims, aren’t regulated as medical devices.[7][8]

Can an ARTG listing be cancelled? Yes. Entries can be cancelled by the TGA or at the sponsor’s request, and cancellations are published. For example, the ARTG entry for one red/infrared light unit was cancelled at the sponsor’s request on 30 June 2026.[10][11]

Is a red light therapy mask “TGA approved” if it has an ARTG number? No device is “TGA approved” in advertising terms. An ARTG number means the device is included in the register for its stated intended purpose. Check that entry yourself.[1]

For personal advice about whether red light therapy suits you, please talk with your GP, dermatologist or another health professional.

Related reading on our blog

• Red light therapy and the TGA in Australia: what the rules actually say
• Medical grade red light therapy devices in Australia: what it means

Sources

1. TGA. The claim “TGA approved” must not be used in advertising. https://www.tga.gov.au/products/regulations-all-products/advertising/specialised-advertising-issues-and-topics/claim-tga-approved-must-not-be-used-advertising
2. TGA. Overview of applying for market authorisation. https://www.tga.gov.au/products/regulations-all-products/overview-applying-market-authorisation
3. TGA. Searching the Australian Register of Therapeutic Goods (ARTG). https://www.tga.gov.au/products/regulations-all-products/about-australian-register-therapeutic-goods-artg/searching-australian-register-therapeutic-goods-artg
4. TGA. ARTG Search (Public) guidance; and Can I advertise this therapeutic good to the public? https://www.tga.gov.au/sites/default/files/2023-06/artgsearchguidance.pdf ; https://www.tga.gov.au/resources/decision-trees/can-i-advertise-therapeutic-good-public
5. TGA. Overview of medical devices and IVD regulation; and Advertising legal framework; and Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, s 24(6)(a). https://www.tga.gov.au/products/medical-devices/overview/overview-medical-devices-and-ivd-regulation ; https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-legal-framework ; https://www.legislation.gov.au/F2021L01661/2022-12-20/2022-12-20/text/original/pdf
6. TGA. Understanding regulation of off-label use of medical devices. https://www.tga.gov.au/resources/guidance/understanding-regulation-label-use-medical-devices
7. TGA. Determining if your product is a cosmetic or therapeutic good. https://www.tga.gov.au/resources/guidance/determining-if-your-product-cosmetic-or-therapeutic-good
8. ABC News (22 July 2026). The claims and evidence behind popular anti-aging and wellness treatments. https://www.abc.net.au/news/2026-07-22/peptides-red-light-nad-wellness-therapies-claims/106937662
9. ARPANSA. Advice for consumers: Lasers, IPL devices and LED phototherapy for cosmetic treatments and beauty therapy. https://www.arpansa.gov.au/understanding-radiation/sources-radiation/more-radiation-sources/lasers-and-intense-pulsed-light-0
10. TGA. Cancellations. https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-actions-and-outcomes/cancellations
11. TGA. Sponsor record and cancellation by sponsor, red/infrared light phototherapy unit (cancelled under s41GL(d) of the Act). https://www.tga.gov.au/resources/sponsor/therapy-lights-australia-pty-ltd
12. US FDA. Premarket Notification 510(k). https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
13. US FDA. Premarket Approval (PMA); and Device Approvals and Clearances. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma ; https://www.fda.gov/medical-devices/products-and-medical-procedures/device-approvals-and-clearances