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FDA 510(k)

KALA MINI 2.0 (KALA-04)

K-Number: K251781 · 2025-09-04

ApplicantShenzhen Kaiyan Medical Equipment Co., Ltd.
Decision Date2025-09-04
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KALA MINI 2.0 (KALA-04) 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 2025-09-04 under 510(k) number K251781. 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 MINI 2.0 (KALA-04)?

KALA MINI 2.0 (KALA-04) is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K251781.

When did KALA MINI 2.0 (KALA-04) receive FDA 510(k) clearance?

KALA MINI 2.0 (KALA-04) received FDA 510(k) clearance on 2025-09-04, under 510(k) number K251781.

Who is the listed applicant for KALA MINI 2.0 (KALA-04)?

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 MINI 2.0 (KALA-04)?

The FDA product code for KALA MINI 2.0 (KALA-04) 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.

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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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