What the record shows
The device is classified under regulation 878.4810 with the device classification name "Light Based Over The Counter Wrinkle Reduction. The product code is OHS, with a subsequent product code of OLP. The regulation medical specialty is General & Plastic Surgery, and the panel is General & Plastic Surgery.
The filing was received August 27, 2026. It went through the traditional 510(k) pathway, not the third-party review pathway. The record says it is not a combination product and is not under a predetermined change control plan.
Shenzhen Bway's applicant contact is Xiuzhu Zhang. The correspondent, which handled the submission for the company, is Flying Drug & Medical Compliance Service Co., Ltd., with Qin Wang as contact. Both are in Shenzhen.
The page was last updated November 9, 2026.
What it means for practices (analysis)
Our read: the classification is the story here. An over-the-counter wrinkle reduction code tells you the FDA put this in the consumer lane, and that lane has a different set of questions than the in-clinic device you might buy for a treatment room. A clinic that sells or uses a home-type LED mask under this clearance should check whether the marketing matches the cleared use. A clearance under a wrinkle reduction classification does not give a practice license to make claims about depth of effect, collagen change or any condition the record does not name.
The other thing to notice is the applicant. Shenzhen Bway is a manufacturer based in China that used a U.S.-based or in-country-type correspondent for the filing. That is common for consumer light devices. It also means a practice that buys inventory will be dealing with a supply chain it cannot audit from a clearance page alone.
What owners can do
Pull the FDA entry for K262984 and confirm your exact model number is one of the eight listed. If it is not on the list, the clearance does not cover your unit, and you should ask the vendor for its own 510(k) number.
Ask the vendor for the labeling and confirm the indications match the classification. If the marketing says anything beyond wrinkle reduction, that is a question for your regulatory counsel before the device goes on the floor.
Keep a copy of the clearance record in your device file. Note the decision date, the 510(k) number and the model numbers. When you train staff, tell them what the device is cleared for and what it is not.
Check your state's rules on light-based devices and on the scope of your staff's use. The FDA clearance does not settle those questions.
What we don't know yet
The database entry does not include the device's output specifications, wavelengths, irradiance, treatment times or labeling text. Those details sit in the full 510(k) summary or the submitted labeling, which the page we reviewed does not show. We also cannot tell from this record which of the eight models differ in hardware, and whether E01 and E02 are the same device sold under a different name. Until the labeling is public, anyone deciding whether a specific model fits their treatment plan will have to request it directly from the applicant.
Business information, not medical or legal advice. Verify regulatory status at FDA.gov.
