FDA WARNING_LETTER - Energy Technology Development Ltd./Wicked Lasers

The FDA issued a Warning Letter to WickedLasers, Ltd. and Energy Technology Development Limited, disapproving their quality control and testing program for all laser products, including models like Core, Spyder, and Pulsar. This action, under the Federal Food, Drug, and Cosmetic Act, prohibits the firms from certifying, introducing, or importing non-compliant or uncertified electronic products into U.S. commerce.

The disapproval stems from the firms' failure to establish a quality test program ensuring compliance with FDA regulations, identified through a review of product reports. Specific violations include: 1. **21 CFR 1002.10(d) Product reports:** Failure to properly identify laser products as surveying, leveling, and alignment (SLA) lasers, contradicting prior FDA communications. 2. **21 CFR 1003.10 Discovery of defect or failure of compliance by manufacturer- notice requirements:** Failure to notify dealers/distributors of violative products as previously required. 3. **21 CFR 1003.11 Determination by Secretary that product fails to comply or has a defect:** Failure to provide the number of produced and distributed violative products. 4. **21 CFR 1004.1 Manufacturer's obligation to repair, replace, or refund cost of electronic products:** Failure to submit a written corrective action plan. 5. **21 CFR 101