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.
- FDA’s Class II Special Controls Designations Are On The Rise; How Will Your Device Be Affected?
- Premarket Notification 510(k)
- Premarket Approval (PMA)
- FDA “Cleared” Versus “Approved”: What’s the Difference?
List of FDA Cleared At-Home Hair Removal Systems
|Products Name||FDA Cleared||Device Type||Where to Buy?|
|Silk'n Flash N Go||Yes 510(k) SUMMARY||IPL||Buy on Silk'n|
|COSBEAUTY PerfectSmooth||Yes 510(k) SUMMARY||IPL||Buy on Amazon|
|Me *||Yes 510(k) SUMMARY||IPL + RF||Buy on Amazon|
|Iluminage *||Yes 510(k) SUMMARY||IPL + RF||Buy on Amazon|
|Remington iLIGHT® Pro||Yes|
Partnered with Shaser BioScience, Inc.
PR. 510(k) SUMMARY
|IPL||Buy on Amazon|
|SensiLight Mini||Yes 510(k) SUMMARY||IPL||Buy on Amazon|
|Tria||Yes 510(k) SUMMARY||Laser Hair Removal||Buy on Amazon|
Buy on TriaBeauty
|* Me & Iluminage are technically the same product|
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/