FDA Regulatory Strategy Consultant – Laser Cap Medical Device Development

Hello, I'm looking for an experienced FDA regulatory consultant to provide guidance with regards to a low-level laser therapy (LLLT) device, specifically a laser cap for hair regrowth. Our goal is to understand whether our LLLT-combination device would be able to get 501(k) FDA-clearance, given that it combines two modalities into one product (more information will be given via direct message). You should have: - Proven experience with FDA medical device submissions, ideally in laser or photobiomodulation devices - Familiarity with 510(k) vs De Novo - Understanding of risk classification, testing standards (IEC 60601, IEC 62471, etc.), and clinical/bench testing requirements - Excellent communication and ability to provide clear, actionable guidance Preferred: - Prior experience getting a laser cap or similar LLLT device cleared via 510(k) - Familiarity with international regulatory frameworks (e.g., CE, Health Canada) is a plus I'd like to set up a consultation call to run through the specifications of the device, with the aim of understanding whether our product could get FDA-clearance, and if so what that process looks like. In your proposal please give me a quick summary of your experience in this field. If you have personally overseen the FDA-clearance of an LLLT device for hair regrowth then let me know. Thanks, Gus Apply Now Apply Now