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We are seeking an experienced FDA regulatory consultant to consult with us regarding the compliance process for 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). all testing and documentation requirements, and ensure the product is fully compliant for marketing in the U.S. You should have: - Proven experience with FDA medical device submissions, ideally in laser or photobiomodulation devices - Familiarity with 21 CFR 890.5500 (infrared lamp, hair regrowth) and related device codes (e.g. OAP, GEX) - 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