Until Sybaritic Inc. is in compliance with FDA standards, it will stop manufacturing devices used in laser surgery, dermatology, and spa treatments. According to an FDA release, agency inspections that were conducted at the company during the past several years showed violations of the QSR, the sale of devices that didn't undergo premarket review, and a failure to submit MDRs to FDA. The QSR violations were related to design controls, complaint handling, CAPA, and quality audits. Sybaritic's SkinBella hasn't been FDA approved or cleared. The company's Dermalife, NannoLight MP50, SkinClear, SRVH, and Dermosonic devices have been cleared for marketing, but Sybaritic made product claims that weren't included in FDA clearances and are considered major changes to the intended use of the devices. According to FDA, these changes could also affect the safety and effectiveness of the devices.