Is Revian FDA Cleared or Approved? What is the difference?
Revian is a class II, FDA-Cleared medical device (#K173729). Because we are considered a red light therapy device similar to others in light output and within the large range of “red” light all we needed to file to was a 510K submission based on other predicate devices. This submission includes all safety testing of our device according to IEC 60601 and others needed for medical devices in this category.
Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to (similar) another legally marketed device. A pre-market notification submission is referred to as a 510(k) and must be submitted to FDA to review and provide clearance.
Approved medical devices: Approved medical devices are those devices that the FDA has approved a pre-market approval (PMA) application or a Humanitarian Device Exemption (HDE) application. This review and approval process is for Class III medical devices (the ones with the highest risk) and involves a more rigorous review than the 510(k) review process.
https://www.fda.gov/medical-devices/resources-you-medical-devices/consumers-medical-devices
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I have dark skin, will the Revian Red system still work?
Revian Red is indicated for use on Fitzpatrick Skin Types I-IV because those are historically the skin types cleared by the FDA in regards to red light therapy and hair loss. Revian's scientists tested Revian LEDs on darker Fitzpatrick skin type VI ...
Is Revian Safe?
Yes, REVIAN is safe! To be more specific: Revian was cleared by the United States Food and Drug Administration (FDA) under 510(k) #K173729 in 2018 according to the federal standards for safety and electromagnetic compatibility Revian has been ...
Can I travel with the Revian Red system?
Yes, you can travel with the Revian Red system.There is no special clearance required by the TSA to carry the Revian Red medical device onboard a commercial aircraft. The Revian Red system is a limited energy device similar to mobile phones that have ...
Is Revian available for purchase outside the United States?
No, at this time the Revian Red system is only cleared by the U.S. FDA for sale in the United States. We are pursuing additional markets and would like to hear from you if you reside outside the United States.The Revian cap may be used outside the US ...
What classifications of hair loss on the Norwood-Hamilton scale is Revian cleared to treat?
Revian promotes hair growth in males who have Norwood-Hamilton classifications of IIa – V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal ...