KALA Red Light Face Mask (KALA-01)
K-Number: K250581 · 2025-05-30
Decision Date2025-05-30
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
KALA Red Light Face Mask (KALA-01) is a medical device manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-05-30 under approval number K250581. 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 KALA Red Light Face Mask (KALA-01)?
KALA Red Light Face Mask (KALA-01) is a medical device that received FDA 510(k) clearance on 2025-05-30. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K250581.
When was KALA Red Light Face Mask (KALA-01) approved by the FDA?
KALA Red Light Face Mask (KALA-01) received FDA 510(k) clearance on 2025-05-30, under approval number K250581.
What company makes KALA Red Light Face Mask (KALA-01)?
KALA Red Light Face Mask (KALA-01) is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd..
What is the FDA product code for KALA Red Light Face Mask (KALA-01)?
The FDA product code for KALA Red Light Face Mask (KALA-01) 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.