FDA WARNING_LETTER - Marci Beauty LLC - February 02, 2021

The FDA issued a Warning Letter to Marci Beauty LLC (d.b.a. Spacetouch) on February 2, 2021, for marketing unapproved and uncleared light therapy devices: Jupiter, Vega, Neptune, Luna, Cosmo, Nova, and Galaxa. The FDA determined these products are medical devices based on claims on www.spacetouch.com, including treating wrinkles, acne, pigmentation, eczema, rosacea, sun damage, skin cancer, bone density, osteoporosis, various cancers, jaundice, heart disease, and diabetes.

The devices are deemed adulterated under section 501(f)(1)(B) of the Act because the firm lacks premarket approval (PMA) or an investigational device exemption (IDE). They are also misbranded under section 502(o) for failure to submit a 510(k) premarket notification. A previous "It Has Come to Our Attention" letter on June 17, 2020, requested clearance/approval numbers, but the firm's July 23, 2020, response, citing a K162489 clearance for a "RED Light Device" by Zhongshan Bisen Plastic Electronic Products Co., Ltd., was deemed inadequate as it was unrelated to the marketed devices and had different indications.

The FDA requires Marci Beauty LLC to cease activities resulting in misbranding or adulteration, such