What is Renuvion cleared for?

Renuvion is the brand name of a device that uses helium plasma together with radiofrequency. Its U.S. FDA 510(k)(a US FDA clearance confirming the device is equivalent to one already cleared) clearances are granted separately by handpiece and by intended use.

The U.S. FDA first issued a safety communication about Renuvion in March 2022 and updated it on 10 May 2023.

How to read the table

The three clearances are for different handpieces and different purposes. Lumping them together as 'Renuvion clearance' loses what was actually cleared. The K numbers can be looked up directly in the U.S. FDA database.

What these figures do not mean

The wrinkle clearance carries a skin-type condition. Koreans are mostly Fitzpatrick types III to IV, which may fall outside the scope of that clearance.

What makes the difference?

• Skin-type restriction — The wrinkle clearance is limited to Fitzpatrick types I to III. Koreans are mostly types III to IV and may fall outside its scope.
• Different handpieces — The three clearances are for different handpieces.
• Combination — The post-liposuction clearance presupposes use together with liposuction.

The three clearances are different things

U.S. FDA 510(k) clearances are granted separately by handpiece and by intended use. K211652 concerns wrinkles, K220970 concerns loose skin in the neck and submental region, and K230272 concerns coagulation of subcutaneous soft tissue following liposuction. One does not cover the others' purposes, so the meaning is only precise when you say what it is cleared for.

The wrinkle clearance carries a skin-type condition

The clearance text of K211652 states the condition of Fitzpatrick skin types I, II and III. Koreans are mostly types III to IV, which may fall outside the scope of that clearance. Leaving out this distinction and saying only 'FDA-cleared device' reads differently from the actual scope. That is why the purpose it is used for has to be confirmed first at consultation.

Safety communication and Korean approval are separate

The U.S. FDA first issued a safety communication about Renuvion in March 2022 and updated it on 10 May 2023. Clearance and safety communication are separate documents, so both are to be checked. U.S. FDA clearance also does not mean approval for use in Korea — Korea has a separate approval procedure through the Ministry of Food and Drug Safety (MFDS).

What to confirm at consultation

• What purpose it is used for, and which of the three above applies
• Whether it is done alone or together with another procedure

Asking about your own case

The table above gives general ranges and does not apply to you as it stands. Rephrasing the question like this at consultation gets you an answer for your own case.

What purpose will you use it for? Which of the three clearances applies? What is its approval status in Korea?

Common misunderstandings

Isn't Renuvion an FDA-approved device?

It is cleared, but separately by handpiece and by intended use. Wrinkles (K211652), neck and submental region (K220970) and soft-tissue coagulation after liposuction (K230272) are each a different clearance, and one does not cover the others' purposes.

Does the same clearance apply to Koreans?

The wrinkle clearance carries a skin-type condition of Fitzpatrick types I, II and III. Koreans are mostly types III to IV and may fall outside its scope. U.S. FDA clearance and Korean MFDS approval are also separate procedures.

Related questions

• What does 'FDA approved' actually mean?
• What is the difference between surgical and non-surgical procedures?
• How do I check whether a clinic is safe?