Fake hair removal and therapy devices pose serious safety risks to patients and practices.
The FDA has issued a public advisory after counterfeit laser hair removal and therapy devices were discovered in some clinics. The agency warns that these devices may pose serious health risks to patients and expose practices to significant liability.
Counterfeit aesthetic equipment typically lacks proper safety testing, calibration, and regulatory documentation. Unlike legitimate 510(k)-cleared devices from manufacturers like Cutera, Cynosure, or Lumenis, knockoffs often have undisclosed energy outputs, faulty cooling systems, and no post-market surveillance. A practice using a counterfeit device faces not only patient injury claims but also FDA enforcement action, state board discipline, and potential criminal charges for knowingly deploying unapproved equipment.
Counterfeit devices lack proper safety testing and calibration.
The advisory underscores the importance of device procurement from authorized distributors. Verify serial numbers, request FDA clearance documentation, and confirm the device is listed on the FDA's CDRH database. Counterfeit equipment is typically sourced through gray-market or international channels at steep discounts—a red flag for any practice owner.
Source: original report ↗
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