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FDA 510(k)

KALA Red Light Face Mask (KALA-01)

K-Number: K250581 · 2025-05-30

ApplicantShenzhen Kaiyan Medical Equipment Co., Ltd.
Decision Date2025-05-30
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KALA Red Light Face Mask (KALA-01) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-05-30 under 510(k) 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. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K250581.

When did KALA Red Light Face Mask (KALA-01) receive FDA 510(k) clearance?

KALA Red Light Face Mask (KALA-01) received FDA 510(k) clearance on 2025-05-30, under 510(k) number K250581.

Who is the listed applicant for KALA Red Light Face Mask (KALA-01)?

The FDA 510(k) record lists Shenzhen Kaiyan Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: OHS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)Shenzhen Qianyu Technology Co., Ltd.K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading LimitedK261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLCK2605985 Wavelength LED Facemask (TN2508)iSMART Developments, Ltd.

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.

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