Solawave 2-in-1 Skincare Mini (Model: 61043)
K-Number: K250532 · 2025-05-22
Decision Date2025-05-22
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Solawave 2-in-1 Skincare Mini (Model: 61043) is a medical device manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-05-22 under approval number K250532. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Solawave 2-in-1 Skincare Mini (Model: 61043)?
Solawave 2-in-1 Skincare Mini (Model: 61043) is a medical device that received FDA 510(k) clearance on 2025-05-22. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K250532.
When was Solawave 2-in-1 Skincare Mini (Model: 61043) approved by the FDA?
Solawave 2-in-1 Skincare Mini (Model: 61043) received FDA 510(k) clearance on 2025-05-22, under approval number K250532.
What company makes Solawave 2-in-1 Skincare Mini (Model: 61043)?
Solawave 2-in-1 Skincare Mini (Model: 61043) is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd..
What is the FDA product code for Solawave 2-in-1 Skincare Mini (Model: 61043)?
The FDA product code for Solawave 2-in-1 Skincare Mini (Model: 61043) is OHS.
Other Devices by Shenzhen Kaiyan Medical Equipment Co., Ltd.
Related Devices (Code: OHS)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.