Medart A/S

Medart A/S specializes in dermatological carbon dioxide (CO₂) laser systems. These devices are primarily designed for skin treatments, such as precision dermatological procedures. Examples include the MedArt Intenz, MEDART 620, MEDART DIODE LASER SYSTEM with accessories, and the MEDART Model 610 CO₂ laser system, which is often paired with complementary accessories for targeted applications.

Medart A/S is based in the United States. As a U.S.-based manufacturer, its devices are subject to U.S. medical device regulations, including classification and registration requirements under the FDA framework. The company’s products are designed to comply with applicable U.S. standards for dermatological laser systems.

Medart A/S’s dermatological laser systems fall under Class II classification. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards, labeling requirements, or post-market surveillance. Class II devices often require pre-market submissions like 510(k) clearances in the U.S.

Yes, Medart A/S’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. Inclusion in the 510(k) registry indicates that the devices have undergone a pre-market submission process to demonstrate substantial equivalence to a predicate device. The UDI registry ensures traceability and transparency in the supply chain, helping healthcare providers verify device identity, compliance, and recall history—critical for patient safety and regulatory oversight.