FDA Cleared Hair Removal at Home

We use the term “FDA Cleared” and not “FDA Approved” that’s because, by the FDA, home hair removal devices are categories as Class II medical devices. Whereas “FDA Approved” categories as Class III. Each medical devices class has different requirements. You can read more about it below.
Manufacturers of home hair removal systems to be able to sell their device, they must go through a pathway to Inspect safety and effectiveness. Which at last the device is “cleared” for distribution.

FDA Approved VS FDA Cleared Products

FDA Approved (PMA-Premarket Approval) is a process that checks the safety and effectiveness for Class III medical device. Devices that support or sustain human life. The FDA does not require PMA from at-home hair removal devices. FDA Cleared it is what at-home hair removal laser & IPL devices are submitting their products to the FDA. These products classified as Class II devices. As mentioned above they’re being tested for safety and effectiveness.

References/Learn More:

List of FDA Cleared At-Home Hair Removal Systems

Products NameFDA ClearedDevice TypeWhere to Buy?
Silk'n Flash N GoYes 510(k) SUMMARYIPLBuy on Silk'n
COSBEAUTY PerfectSmoothYes 510(k) SUMMARYIPLBuy on Amazon
Me *Yes 510(k) SUMMARYIPL + RFBuy on Amazon

Iluminage *Yes 510(k) SUMMARYIPL + RFBuy on Amazon
Remington iLIGHT® ProYes
Partnered with Shaser BioScience, Inc.
PR. 510(k) SUMMARY
IPLBuy on Amazon
SensiLight MiniYes 510(k) SUMMARYIPLBuy on Amazon
TriaYes 510(k) SUMMARYLaser Hair RemovalBuy on Amazon
Buy on TriaBeauty


* Me & Iluminage are technically the same product

Find out more, read our Questions and Answers on home hair removal devices. Or go to our top products comparison chart.

Searching the FDA Database for FDA-Cleared At Home Laser Hair Removal

If a product is not listed on our site and you want to find out if it is FDA Cleared. Visit the FDA database https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
To search right, try searching by “Applicant Name” or by “Device Name” separately. if either one does not generate results head to Google and search for “product name” + “FDA” or “product name” + “510(k)” and look for the FDA website https://www.accessdata.fda.gov/