Learn
Is PLUNA FDA cleared?
Short answer
No. PLUNA is not FDA cleared or approved, because it is not sold as a medical device. It is a beauty device designed for home use, and it is not in the FDA’s Class I category for plasma-based massage devices. PLUNA complies with FCC rules for electromagnetic emissions (Part 15, Class B, the limits for electronics used at home). Its maker, FEAGLE, is also certified to ISO 9001 and ISO 13485 for quality management.
What each certification covers
- FCC Part 15, Class B. PLUNA (model AC-01) was tested by Standard Bank Co., Ltd., a Korean test laboratory, in March 2025, and complies with FCC limits on electromagnetic emissions for electronics used at home, so it does not interfere with radios, phones and other devices. It is authorized through a Supplier’s Declaration of Conformity (test report E25WD-099), the route for devices without a wireless radio, so PLUNA has no FCC ID. It is not a judgment about results.
- TÜV SÜD attestations. Independent attestations of conformity for electrical safety and for electromagnetic compatibility, issued in 2024 to FEAGLE Co., Ltd. for PLUNA models AC-01-W and AC-01-T.
- ISO 9001. Quality management systems, held by PLUNA’s maker, FEAGLE.
- ISO 13485. Quality management systems for medical devices, also held by FEAGLE. It covers how the company designs and makes products.
None of these is a medical device clearance or approval, and PLUNA is not presented as one.
Why PLUNA is not FDA cleared
FDA clearance applies to medical devices. PLUNA is sold as a beauty device for home use, and everything PLUNA says about it is about how skin looks and feels, never about treating a condition. The FDA does have a Class I category for plasma-based massage devices; PLUNA is not in it.
What this means for you
- PLUNA makes no medical claims. It is not intended to diagnose, treat, cure or prevent any condition.
- Refer to the current Instructions for Use for contraindications, warnings and precautions. It ships with the device.
- For questions about a skin condition, implants or medication, ask your healthcare professional. support@plunapro.com can help with product questions.