What the listing shows
The device is classed under the name "Light Based Over The Counter Wrinkle Reduction. The regulation number is 878.4810. The product code is OHS, with a subsequent product code of OLP. The medical specialty is General & Plastic Surgery, and the panel is General & Plastic Surgery.
The review was not done by a third party. The submission is not a combination product, and it does not carry a Predetermined Change Control Plan.
The correspondent is Feiying Drug & Medical Consulting Technical Service Group, also in Shenzhen. The applicant contact is listed as Chan Fu. The correspondent contact is Axiu Yang.
What it means for practices (analysis)
This is a 510(k) for an over-the-counter wrinkle device. The classification language is the important part. A device cleared under this name is a consumer-facing product that a shopper can buy without a prescription or a clinic visit. It is not a professional treatment device that a licensed operator runs on a patient.
That matters for your business in one specific way. If the AMIRO mask is sold at retail or online, it competes for the same wrinkle-minded customer who books a facial or a light treatment in your room. It does not compete for a clinical procedure. I would price that threat as low-intensity but constant, the way at-home LED has always worked.
The other thing to watch is how the device gets described in marketing. An OTC clearance covers a stated use. Any claim that goes past that use, or any suggestion that the mask does what a clinic device does, is a labeling question, and it is not a question the FDA listing answers for you.
What owners can do
Pull the FDA entry and read the device name and classification text yourself before you repeat any claim about this product to a client. The name is in the listing, and the listing is what regulators will compare against.
If a client asks about the AMIRO mask, explain the difference between an OTC device and in-office treatment in plain language. Know which uses are on the label, and know that the 510(k) does not clear the device for any use beyond the one in its classification.
If you sell at-home devices, check the labeling you are allowed to use under the clearance before you put it into a sales script.
What we don't know yet
The FDA listing does not include the full indications for use, the device labeling, the predicate device, or the performance testing submitted with the file. Those documents may be available through FDA's public 510(k) file, but this listing does not contain them, so I cannot say what the mask is labeled to treat or what the predicate is.
I also cannot confirm the device's retail availability in the United States. The listing does not name a distributor, a launch date, or a price. Anyone who tells you the mask is on shelves is working from a source this document does not supply.
Business information, not medical or legal advice. Verify regulatory status at FDA.gov.
