Ostar Beauty Sci-Tech Co Ltd. – FDA Warning Letter, May 28, 2024

The FDA issued Warning Letter CMS: #667871 to Star Park II Daxing Qu Beijing Shi on December 04, 2023, for marketing unapproved and uncleared medical devices in the United States. The FDA reviewed the firm's website (ostarbeauty.com) and identified several products as devices under section 201(h) of the Act due to their intended use for disease treatment, mitigation, cure, prevention, or affecting body structure/function.

Violations include: 1. **Adulteration (Section 501(f)(1)(B)):** The listed devices lack premarket approval (PMA) or an approved investigational device exemption (IDE). 2. **Misbranding (Section 502(o)):** The firm failed to provide premarket notification (510(k)) for these devices. 3. **Misbranding (Section 502(o)):** The firm has not fulfilled annual establishment registration and device listing requirements for fiscal year 2023, as mandated by section 510 of the Act.

The identified devices include various microneedling devices, LED therapy masks, a laser hair growth helmet, a cryolipolysis fat freezer, and an electroporation mesotherapy machine. Due to these violations, the devices are subject to refusal of admission into the U.S. under section 801