How to check an "FDA cleared" claim

1. Find the number

Look on the box, in the manual, or on the product page. There are two kinds of number:

• K followed by six digits, like K261601, is a 510(k) number.
• DEN followed by six digits is a De Novo number. A De Novo grant isn't a 510(k) clearance.

If the seller says "FDA cleared" but gives no number, ask for it.

2. Look it up

Type the number, brand or company into the search on our home page, or go to FDA's databases:

• K numbers: FDA's 510(k) database. A 510(k) clearance shows the decision "Substantially Equivalent".
• DEN numbers: FDA's De Novo database. A De Novo grant shows the decision "Granted". It is not a substantial-equivalence decision.

3. Match the company and the device

The record names the applicant, the company that filed. It may be the brand or a manufacturer that makes the device for the brand; often the device name as filed includes the brand name. If neither the company nor the device name connects to what you're buying, ask the seller to explain how the number relates to the product.

4. Match the model

Many records list model numbers. For example, record K261601 was filed by Shenzhen Chuangtong Yigou Technology Co., Ltd. as “LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)”. If your model isn't named, the record alone doesn't establish that it's covered. The device name field isn't always a complete model list, and some changes to a device don't need a new 510(k), so ask the seller which record covers your model.

5. Read what it was cleared for

The indications for use say what FDA cleared the device for. The same record says:

“The LED Light Therapy Mask is an over-the-counter (OTC) device intended for the following uses: For Red+NIR Mode: Treatment of full-face wrinkles. For Blue+Red+NIR mode: Treatment of mild to moderate inflammatory acne.”

That record lists both wrinkles and acne. Another record may list only one. Clearance for one use doesn't by itself establish clearance for another, so read the statement for the record that names your device. Claims on the box that go beyond the indications aren't established by the clearance.

Watch the wording

• "FDA approved" is a different status from cleared. See cleared vs approved.
• "FDA registered" or "made in an FDA-registered facility" is the seller's claim that an establishment is registered. Registration isn't a clearance, and the claim on the box doesn't show that the registration is current.
• "Uses FDA-cleared technology" can refer to another company's device. Ask for this device's number.

If you can't find a record

That doesn't show that the device isn't cleared. The name on the box may differ from the name filed, or the device may be filed under a code we don't cover. Ask the seller for the K or DEN number and check it in FDA's database.

This page explains how to read FDA records. It isn't advice about whether a device is right for you; ask a licensed clinician about that.