Damae Medical - FDA 510(k) Cleared Devices

Damae Medical, develops advanced imaging systems for skin analysis and clinical diagnostics. Based in Paris, France, the company specializes in non-invasive medical devices for dermatology and General & Plastic Surgery applications. The company's flagship technology, deepLive™, integrates LC-OCT (Line-field Confocal Optical Coherence Tomography) for 3D skin imaging with cellular resolution.

Damae Medical has received 2 FDA 510(k) clearances from 2 total submissions, with all submissions focused on General & Plastic Surgery devices. The company achieved its first FDA clearance in 2024 and most recently in 2025, demonstrating active regulatory engagement. The deepLive™ system received CE Mark Class IIA approval under EU MDR 2017/745 in 2023 and is now installed across Europe, Japan, Australia, and the United States.

Founded in 2014 by Anaïs Barut (CEO), David Siret (CTO), and Arnaud Dubois (CSO), Damae Medical has built a strong foundation in optical imaging technology. The company raised €5 million in Series A financing in 2022 and maintains R&D and production facilities in Paris. Over 170 scientific publications document the clinical validation and applications of LC-OCT technology for skin cancer detection and analysis.

Explore the company's cleared device names, product codes, and specific clearance dates in the database.

510(k) submissions have been managed by Cosm as regulatory consultant.