MINT™ makes history as the first PDO thread to receive three FDA clearances
FDA Cleared PDO Threadsw Title
MINT™ makes history as the first PDO thread in the US to receive three FDA clearances.
MINT™ stands for Minimally Invasive Nonsurgical Thread and is manufactured by HansBiomed in a state-of-the-art facility at its research center in South Korea. MINT™ prides itself on being unique and different from other types of PDO threads because of its several advantages and improved features. These features include patented press-molded barbs, patented 360 degree helical barb design, and three 510(k) clearances from the FDA.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).
MINT™ received its first 510(k) clearance in 2013 and was indicated for use in soft tissue approximation where use of absorbable sutures is appropriate (K130191). It received its second 510(k) clearance in 2020 that stated MINT was indicated for use in mid-face suspension surgery to temporarily fixate the cheek subcutanous fat layer and SMAS layer in an elevated position for the treatment of moderate to severe nasolabial folds (K192423).
The third 510(k) clearance was approved on March 7th, 2023 and has expanded the indications for use, included additional MINT™ suture types and models, and included additional accessory to facilitate suture implantation.
The clearance states the MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures) are comprised of PDO and are indicated for use in soft tissue approximation where use of a barbed absorbable suture is appropriate. These sutures are also indicated for use in face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position (K220549). Examples of face suspension surgery includes lifting of the temporal, midface, and lower face (nasolabial folds, jowls, jawline, neck, eyebrows, nose, etc). The clearance also reviewed that MINT’s stainless steel cannula material (SUS 304) is biocompatible and is reviewed by the FDA.
MINT™ is continually innovating and pioneering the aesthetic industry to bring the highest quality of PDO threads there are to offer. Discover why more and more providers are choosing MINT™ as their PDO thread of choice.
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