FDA records, quoted · fetched October 12, 2026
Is it FDA cleared?
Look up LED masks, laser and IPL hair removers, hair-growth caps, microcurrent and RF skin devices in FDA's own records. Each record shows the FDA number, the company that filed, the device name as filed and the decision date, and, where we could copy it cleanly from FDA's PDF, the indications for use.
Text search of 614 records in the 8 FDA product codes this site covers. A record shows up when its company or device name contains every word you type, as whole words. Your search appears in the page address.
Examples: NuFACECurrentBodyLightStimHairMaxBraunOmniluxTheradomeForeoZIIPUlike
Browse by device type
FDA files each device decision under a product code. These are the 7 consumer-device codes this site covers; it doesn't cover every code a beauty device could be filed under (see what's left out). Each page quotes what FDA says the code covers and lists every record in it.
163 records · code OHS
LED and light devices for wrinkles
Records FDA files under its code for light-based over-the-counter wrinkle reduction. Most are LED masks, panels, wands and eye devices; individual records can list other or additional uses.
51 records · code OLP
LED and light devices for acne
Records FDA files under its code for over-the-counter light-based acne devices. Most are blue or blue-and-red LED masks, patches and wands; individual records can list other or additional uses.
1 record · code OZC
Heat devices for acne
Records FDA files under its code for over-the-counter thermal acne treatment: handheld devices that apply heat to a blemish.
165 records · code OHT
Laser and IPL hair removal (mostly over-the-counter; 1 record says prescription use)
Records FDA files under its code for light-based over-the-counter hair removal: handheld laser and intense pulsed light (IPL) devices. One record's quoted indications say the device is for prescription use; that entry carries a Prescription badge.
114 records · code OAP
Laser and LED hair-growth caps, helmets and combs (1 record says prescription use)
Records FDA files under its hair-growth laser code: caps, helmets, bands and combs. FDA's code name doesn't say over-the-counter, and some records are for professional systems, so read each record. One record's quoted indications say the device is for prescription use; that entry carries a Prescription badge.
12 records · code PAY
At-home radiofrequency (RF) wrinkle devices
Records FDA files under its code for over-the-counter radiofrequency wrinkle devices: handheld devices that heat the skin with radiofrequency energy.
82 records · code NFO
Electrical stimulation for aesthetic use (microcurrent and EMS)
Records FDA files under its code for transcutaneous electrical stimulators for aesthetic purposes, such as facial stimulation. FDA's code name doesn't say over-the-counter, so read each record.
Prescription devices
Listed separately, because they aren't consumer at-home devices.
Cleared, granted, approved, registered
Marketing uses these words loosely. FDA doesn't.
Cleared
A 510(k) clearance: FDA found the device substantially equivalent to a legally marketed device, for the use stated in the record. 612 records here.
Granted
A De Novo grant: FDA classified a new type of device into Class I or II where there was no legally marketed predicate to compare it to. It can then serve as a predicate for later 510(k)s. 2 records here.
Approved
For devices, approval comes through pathways such as premarket approval (PMA) or humanitarian device exemption (HDE). None of the records here are approvals.
Registered
Registration tells FDA where an establishment is; listing tells FDA which devices it makes or handles. FDA says that "does not denote approval".
What each word means, in FDA's own words
Giving one as a gift this holiday?
- Find the FDA number on the box, the manual or the product page. A 510(k) number starts with K; a De Novo number starts with DEN.
- Search it here or in FDA's database, and check that the company and device name connect to what you're buying.
- Check the model. If the record doesn't name your model, the record alone doesn't establish that it's covered; ask the seller which record does.
- Read what it was cleared for. Clearance for one use, such as acne, doesn't by itself establish clearance for another, such as wrinkles. Some records list both.
Newest records
- Braun Aura 9 (6042)
- Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)
- Hair Growth Comb (X-GC01)
- Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)
- LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))
- PureLift Pro Max
- SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)
- Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)
openFDA says its data was last updated September 28, 2026, and we fetched it on October 12, 2026. Decisions that weren't in openFDA's data by September 28, 2026 aren't here.
Questions
What does "FDA cleared" mean for a beauty device?
It means a 510(k) clearance. FDA's 510(k) page says that a company whose device needs a 510(k) must receive an order from FDA finding it substantially equivalent to a legally marketed device before marketing it, and that this order "clears" the device. Some devices are exempt from 510(k), and not every change to a cleared device needs a new one. A clearance is about the device described in the record, for the use stated there. It isn't a guarantee of results.
Is "FDA cleared" the same as "FDA approved"?
No. FDA approves devices through pathways such as premarket approval (PMA), its review of the safety and effectiveness of Class III devices, and humanitarian device exemption (HDE). Of the 614 records on this site, 612 are 510(k) clearances and 2 are De Novo grants; none is an approval. A product described as "FDA approved" still needs a record that names it.
A listing says the device is "FDA registered". Is that a clearance?
No. Establishment registration tells FDA where a device establishment is; device listing tells FDA which devices it makes or handles. They are separate requirements, and which ones apply depends on what the establishment does. FDA says registration or listing "does not denote approval". A claim on a box or listing is the seller's claim. A clearance is a separate decision with its own number that you can look up.
Why can't I find the device I'm looking at?
Records use the name and model numbers the company filed, which can differ from the name on the box, and the applicant is often a manufacturer rather than the brand. The device may be filed under a product code this site doesn't cover. When a search finds nothing, we say we can't establish a match, not that the device isn't cleared. Look for a K or DEN number on the box, manual or product page and search that.
Does a search result mean my exact model is cleared?
No. Search shows records whose company or device name contains all of your words. That is a text match, not a verified product match. Open the record and check that it names your device and model. If it doesn't, we can't establish from the record that your model is covered; ask the seller which record covers it.
Does this site rate or recommend devices?
No. We list what FDA's records say and link the records. We don't rank devices, test them, or say whether they work, and we don't earn commission on sales. The site is supported by ads.