FDA WARNING_LETTER - Eclipse Aesthetics LLC

The FDA issued a Warning Letter to Eclipse Aesthetics, LLC. regarding their TropoCells Autologous Platelet Preparation Kit (Eclipse PRP™). The device was cleared under 510(k) BK110035 for preparing PRP to be mixed with bone grafts for improving handling characteristics in bony defects.

However, the FDA found that Eclipse Aesthetics was marketing Eclipse PRP™ for new, uncleared intended uses, specifically for cosmetic dermatology (e.g., anti-aging, skin resurfacing) and hair loss treatment, as evidenced by claims on their website and social media. These new uses represent major changes to the cleared indications and could significantly affect the device's safety or effectiveness.

The FDA cited several violations: - **Adulteration (Section 501(f)(1)(B) of the Act):** Marketing the device for new intended uses without an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE). - **Misbranding (Section 502(f)(1) of the Act):** Failure to bear adequate directions for its intended uses. - **Misbranding (Section 502(a) of the Act):** False and misleading information on their website, lacking adequate descriptions of risks, warnings, and contraindications, and making unsubstantiated claims. - **Misbranding (Section 502(o) of the Act):** Failure to provide notice to the