Silkn Beauty Ltd.

Silk'N Beauty, Ltd. specializes in cosmetic medical devices primarily for home use. Their portfolio includes red-light phototherapy systems aimed at skin rejuvenation, radio-frequency applicators designed for surface-level skin treatments, and phototherapy lamps that combine blue, red, and infrared wavelengths for targeted skin applications. These devices are intended to address aesthetic concerns like skin texture, tone, and minor imperfections.

Silk'N Beauty, Ltd. is based in the United States. The company focuses on developing and manufacturing cosmetic medical devices that leverage light and radio-frequency technologies to improve skin appearance. Their devices are designed for consumer use at home, targeting non-invasive skin treatments.

Silk'N Beauty, Ltd.’s devices are classified under Class II in the US. This classification is typically assigned to devices that pose a moderate risk and require special controls to ensure safety and effectiveness. Since these devices involve light-based therapies and radio-frequency treatments for cosmetic purposes, regulatory authorities determine that additional controls—such as performance standards, labeling requirements, or post-market surveillance—are necessary to mitigate risks like improper use or unintended skin reactions.

Silk'N Beauty, Ltd.’s devices are listed in the FDA’s 510(k) database and the FDA’s Unique Device Identifier (UDI) system. The 510(k) registration demonstrates that the company has submitted premarket notifications to the FDA, asserting that their devices are substantially equivalent to legally marketed predicate devices. The UDI system ensures traceability and transparency in the supply chain, allowing regulators and healthcare providers to track devices throughout their lifecycle.

Silk'N Beauty, Ltd.’s devices are registered under 510(k) because this is the FDA’s premarket submission process for Class II devices, proving they meet regulatory standards for safety and effectiveness by comparing them to existing, legally marketed devices. The UDI registration is required by FDA regulations to uniquely identify each device, ensuring better tracking, recall management, and post-market surveillance. Together, these registries help maintain compliance and transparency in the medical device supply chain.