Where the data comes from

We queried the openFDA device classification and 510(k) endpoints for the 8 product codes this site covers on October 12, 2026. openFDA's metadata says its data was last updated September 28, 2026, so decisions that weren't in its data by then aren't here, even ones FDA made before our fetch. The query returned 614 records: 612 510(k) clearances and 2 De Novo grants, from 2001 to September 25, 2026, filed by 301 companies.

The queries, in full:

OHS: /device/510k.json?search=product_code:OHS&limit=1000 (163)
OLP: /device/510k.json?search=product_code:OLP&limit=1000 (51)
OZC: /device/510k.json?search=product_code:OZC&limit=1000 (1)
OHT: /device/510k.json?search=product_code:OHT&limit=1000 (165)
OAP: /device/510k.json?search=product_code:OAP&limit=1000 (114)
PAY: /device/510k.json?search=product_code:PAY&limit=1000 (12)
NFO: /device/510k.json?search=product_code:NFO&limit=1000 (82)
QAI: /device/510k.json?search=product_code:QAI&limit=1000 (26)

Download the frozen dataset: smartbeautydevices-2026.json. Its sha256 is a4f4c250191b2695b7ee6da9f47d3451d0644cc32b635e91acbc7f63bb15760c. It is public FDA data plus our extraction fields.

What we checked, and how

FDA web pages we quote (definitions, regulations, the microneedling page, and the De Novo decision summary for microneedling): on October 12, 2026 a script fetched each page and confirmed that every quoted sentence appears on it word for word.
Product code descriptions: the same script copied the Definition, Physical State, Technical Method and Target Area fields from FDA's Product Classification page for each code.
Record fields (number, company, device name, dates, decision) come from openFDA. We compared a sample of 43 records, including both De Novo grants, against FDA's 510(k) and De Novo database pages; all matched, and the De Novo pages show "Granted". The other records weren't individually compared.
Indications for use: we downloaded each record's decision document from accessdata.fda.gov and copied the statement from the PDF's text. 309 records have a quoted statement. We quote one only when it comes from a page with real text rather than a scanned image, when its start and end are clear, and when every word is a dictionary word, part of the record's own names, or a term used in at least three records' statements. A script confirmed that each quote appears in its PDF's text. People didn't proofread the quotes against the rendered pages. Of the other records, 157 have no clean, complete statement we could find; 102 have the statement on a scanned page whose text was machine-read; 16 contain words we couldn't confirm, such as typos or run-together words; 16 unclear classification text; 8 are scanned PDFs with no text; 6 have no PDF at FDA's usual address. Those entries say why and link the PDF.
Source discrepancies: where a quoted statement names a model identifier that isn't in the device name in FDA's database, the entry says so and shows both as FDA has them.

How we present it

Search is a text search. A record shows up when every word you type is a whole word of its company name, device name or number. A result isn't a verified product match; the record's own device name and models are what to check. When nothing matches, we say we can't establish a match, not that the product isn't cleared.
510(k) records are labelled "510(k) cleared" and De Novo records "De Novo granted". openFDA lists De Novo decisions as "Unknown"; FDA's De Novo database shows them as granted.
Device names, company names and indications are FDA's text. We remove line breaks, join words hyphenated across lines, and replace ligature characters from the PDFs; we don't correct anything else.
Device-type names ("Light for wrinkles" and so on) are our labels for FDA product codes. An individual record's indications can differ from its group's label.
Powered microneedling (code QAI) is listed separately as prescription devices, with the source cited on its page.
We don't rank or rate devices, test them, or say whether they work or are safe for you.
Company names are grouped only when they differ by capitals, spacing or punctuation.

What we left out

Surgical and clinic laser and light codes (GEX, ONF, ONE): they mix home and professional devices, and the record data can't tell them apart.
Infrared lamps and low-level lasers for pain (ILY, IOB, NHN): some red-light panels are filed here, but the cleared use is heating or pain relief.
Body contouring and cellulite systems (PBX, NUV, OYW, PKT): professional equipment.
Code NYX (limited-output aesthetic stimulators): openFDA has no 510(k) records for it.
Products with no record: we can't list what FDA hasn't recorded, and we don't list products as "not cleared".
Records filed under a second product code: openFDA lists each record under its primary code only.

Updates

We plan to refresh the data before the holidays and then quarterly. Until then, decisions added to openFDA after September 28, 2026 won't appear.

Privacy, ads and analytics

Search matching runs in your browser, but what you search for is added to the page address (for example /?q=NuFACE), so it is sent to our server when that address is loaded, reloaded or shared, and it can be recorded by Google Analytics, which this site uses to count visits. The site also shows Google AdSense ads. Ads are placed by Google and aren't endorsements. We don't use affiliate links or take payment from device companies. Read our privacy policy.

Corrections

If a record looks wrong here, check FDA's database page linked from the entry first, since that is the authority. If our copy differs from FDA's, or you think we've missed a product code, tell us through North Coast AI and include the record number and a link. We fix verified errors and never charge for a correction.

Who makes this

Smart Beauty Devices is an independent reference published by North Coast AI LLC in Ohio. It isn't affiliated with FDA or with any company named here. It was built with AI assistance and reviewed by Bill Burkey.

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