Guide

FDA cleared vs FDA approved, and how to check either one

These two phrases are used interchangeably in beauty marketing and they mean completely different things. One of them does not apply to any device on this site.

By Selena H. · Published October 13, 2026

Illustrative photograph, not a picture of a specific device.

Definitions

What the two words mean

	510(k) clearance	Premarket approval (PMA)
Applies to	Most Class II devices	Class III, highest-risk devices
What is demonstrated	Substantial equivalence to a device already legally marketed	Reasonable assurance of safety and effectiveness, with clinical data
Typical evidence	Comparison to a predicate device, bench testing	Clinical trials
Applies to home skincare devices?	Yes - this is what they hold	No
Correct phrase	FDA cleared	FDA approved

There is a third route, De Novo, used when a device is low-to-moderate risk but has no predicate. It is rarer and stronger than a 510(k).

A 510(k) is not a rubber stamp. The manufacturer has to identify a legally marketed predicate device, demonstrate substantial equivalence in intended use and technological characteristics, and submit supporting data. The FDA reviews it. That is a real process and a cleared device has been through it.

What a clearance is not is a finding that the device works for you. Substantial equivalence to an existing device is a comparison, not a performance guarantee, and it says nothing at all about irradiance or delivered dose.

The stronger signal

The De Novo route, and who holds one

When a device is low-to-moderate risk but genuinely novel - no predicate exists - the manufacturer can request De Novo classification. The FDA then evaluates safety and effectiveness directly and, if granted, creates a new classification. It is a higher bar than a 510(k).

Almost nothing in home beauty tech has one. The exception we found is NEWA, whose Skin Therapy System holds DEN150005 from 18 December 2015. That is the strongest regulatory position of any device covered on this site, and it is the reason the NEWA appears in our RF roundup despite an older industrial design.

Reading a clearance

Product codes: the part that catches people out

Every clearance has a three-letter product code identifying what the device is cleared to do. A clearance in the wrong code does not support the claim being made.

Code	What it covers	Example
OHS	Light-based over-the-counter wrinkle reduction	CurrentBody Series 2 (K250966), Shark CryoGlow (K242796), TheraFace Mask (K230293)
OLP	Light-based over-the-counter acne treatment	Omnilux CLEAR (K210948)
NFO	Over-the-counter powered facial toning	NuFACE Trinity+ (K201782), ZIIP (K161484), FOREO BEAR (K200803)
OHT	Light-based over-the-counter hair removal	Braun Silk-expert Pro 5 (K190354), Ulike UI20 (K241998)
PAY	Radiofrequency for non-invasive skin treatment	TriPollar STOP U (K220322), CurrentBody Skin RF (K232424)
OAP	Low-level laser for hair growth	All four iRestore clearances

Codes as recorded in the FDA 510(k) database, checked 13 October 2026.

The iRestore row is the instructive one. Four clearances, all genuine, all under OAP for hair growth - and the company also sells a face mask, for which we found no record. We work through that example here. A brand's clearance count tells you nothing until you read the codes.

Do it yourself

How to check a device in five minutes

Open the FDA 510(k) premarket notification database. It is free and needs no account.
Search by device name as printed on the box. Many consumer devices are cleared under a model code rather than the retail name, so try both.
If nothing returns, search by applicant: the brand, then its parent company, then any contract manufacturer named on the packaging or in the manual.
Read the product code against the claim being made. Blue diodes under an OHS clearance have not been reviewed for acne.
Check the decision date. A 2008 clearance for a discontinued predecessor tells you nothing about today's device.
Record a blank as a result. If nothing comes back, the claim on the box is one you cannot verify. That is useful information.

Being careful

What an absent record does and does not prove

On this site, when we write that we could not locate a clearance, we mean exactly that: we searched the public database the way any buyer could and nothing came back. A record may exist under a name or applicant we did not try. Some devices are legally sold without a 510(k).

What it does mean is that the verification path is closed to you. Given the choice between two similar devices where one's claim is checkable and one's is not, the checkable one is the safer purchase, and that is the whole basis on which this site ranks things.

Red flags

Phrases to treat as warnings

“FDA approved” on any consumer skincare device. Wrong word, every time.
“FDA registered” or “FDA listed”. Establishment registration means a facility told the FDA it exists. It is not a device review.
“Cleared” with no number offered anywhere. The number is public; a brand that will not give it has made a choice.
A clearance cited for a different product in the range. Check the code and the device name, not the brand.
“Clinically proven” with no linked study. If the trial exists, the link exists.

FAQ

Questions people actually ask

Is any LED face mask FDA approved?

No. Approval is reserved for the highest-risk Class III devices and no consumer LED mask holds one. Some masks are FDA cleared through the 510(k) process, which demonstrates substantial equivalence to an existing device. Any marketing saying approved is wrong.

What does FDA cleared actually mean?

The manufacturer filed a 510(k) premarket notification showing the device is substantially equivalent to one already legally on the market, for a stated indication, and the FDA reviewed it. It is a real review, and it is not a finding that the device will work for you.

How do I find a device's 510(k) number?

Search the FDA's free public database at accessdata.fda.gov by device name first, then by brand or contract manufacturer as applicant. Check that the product code matches the claim and that the decision date is recent enough to refer to the device on sale.

What is a De Novo authorization?

A route for low-to-moderate risk devices with no existing predicate. The FDA evaluates safety and effectiveness directly and creates a new classification. It is stronger than a 510(k) and rare in home beauty devices - NEWA's DEN150005 is the one we found.

Does FDA clearance mean a device is effective?

No. It means the device was shown to be substantially equivalent to a legally marketed predicate for a stated indication. It says nothing about irradiance, dose, or how well it will work on your skin.

Sources