At-Home Beauty Device FDA 510(k) Reference: What Is Actually Cleared

Five phrases that are not interchangeable

FDA cleared

The manufacturer filed a 510(k) premarket notification and FDA found the device "substantially equivalent" to a legally marketed predicate. Clearance concerns safety and equivalence for the stated indications; it is not an FDA endorsement and not proof of cosmetic results.

FDA approved

A Premarket Approval (PMA) — the higher bar used for Class III devices. No consumer beauty device in this table holds a PMA. Marketing that says "FDA approved" for an IPL or LED device is, at best, using the wrong word.

Registered / listed

Manufacturers must register their establishment and list their devices with FDA. Registration and listing are administrative and do not mean FDA reviewed or cleared the device.

Product-family evidence

A record names the product line (e.g. "Silk.expert Pro 5", "CryoGlow (FW3XXXX)") or the applicant's model families, but the exact retail code you buy is not printed on it. Common: colourways and retail bundles rarely appear on a 510(k).

Exact-model evidence

The model code printed on the product or listing appears verbatim on the FDA record (e.g. UM10, JML1). This is the only case where we say the exact product you buy is the cleared device.

No record located

Our searches of the 510(k) database by device name and applicant returned nothing for this product. That is a statement about what we could find, not a finding of non-compliance: some products are not regulated as devices, and some are cleared under an OEM's name.

The table

Sort or filter. Each K-number opens the FDA decision letter / 510(k) summary. The mapping column is the point of this page: it says whether the record names the exact product you can buy, only its product line, only the applicant, or nothing at all.

Worked case: Ulike, 23 clearances, zero that name the "Air 10"

Shenzhen Ulike Smart Electronics holds 23 510(k)s between June 2022 and May 2026 (below). They clear IPL devices by internal model family — UI04, UI06, UI06S, UI20, UI20S, UIM20, MI01, Y6S — and two LED masks (UM10, JD20U). No record uses the retail name "Air 10", and the retail listing prints no internal code, so the Air 10 is shown as NOT VERIFIED FOR EXACT MODEL: the manufacturer's clearances are real; the link to that specific box is not established from a primary source. K243492, often cited alongside Ulike IPL claims, actually clears the ReGlow LED mask (UM10) — a different product, and an exact-model match for that mask.

Methodology

• Sources: the FDA 510(k) Premarket Notification database queried through openFDA (api.fda.gov/device/510k.json) by device name, applicant and K-number, and the decision letter / 510(k) summary PDF on accessdata.fda.gov for every K-number shown. Model codes are transcribed from the PDF's trade name or model list.
• Consumer identity: the product is the exact ASIN shown; consumer model codes are those printed on the listing or manual. A record is mapped to a product only when the product line, wildcard family or model code on the record can be matched — the mapping confidence column states which.
• Brand claims are recorded separately and never adopted as findings. Reviews, press and forum posts are not sources for this table.
• Each row carries the searches actually executed and the date they were run. Rows are re-verified when the operator republishes the table; the page shows the dataset's last-verified date.
• Beautivara is an affiliate publisher. Links to Beautivara reviews on this page are contextual navigation; there are no affiliate links in the table and the table is usable without visiting any review.

Correction policy

• If a record is misattributed, a model code is transcribed wrongly, or a newer 510(k) supersedes a row, write to partners@beautivara.com with the K-number and the accessdata.fda.gov link. Manufacturers and applicants may also send the consumer-SKU ↔ cleared-model mapping; if the primary record supports it, the row moves to EXACT_MODEL.
• Corrections are applied to the governed dataset (versioned), the page and the CSV together; the changed row shows its new last-verified date. We do not remove rows on request; we correct them.