Feeltech Co., Ltd. · Class II · Cleared Oct 20, 2025
| K-number | K251414 |
| Device name | Miracu Polydioxanone (PDO) Suture and Needle (MONO) |
| Applicant | Feeltech Co., Ltd. |
| Product code | NEW |
| Device class | Class II |
| Decision date | Oct 20, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4840 |
The Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) is a sterile, absorbable surgical suture made of dyed polydioxanone for soft tissue approximation in dermatological applications on the skin only. It is not intended for interior body cavity applications or for lifting and supporting tissues. The suture is sterilized via ethylene oxide gas and degrades over time in tissue.
The device is a non-barbed, monofilament polydioxanone suture with violet dye (D&C Violet No.2) attached to a needle. It is available in sizes 4-0, 5-0, and 6-0, matching United States Pharmacopeia standards. The non-barbed design maintains equal or stronger tensile strength compared to barbed configurations, using the same material, sterilization method, and packaging as predicate devices.
ASTM F1840-10, ASTM F1874-98, ISO 7864:2016, ISO 9626:2016, USP 37-NF32:2014 (Absorbable Surgical Suture, Diameter, Needle Attachment, Tensile Strength), and ASTM D1683 (Seam Strength Testing). Testing verified compliance to FDA-recognized consensus standards for mechanical properties, absorption, and tensile strength retention.
View the full FDA submission: accessdata.fda.gov