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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 a medical device manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-09-04 under approval 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. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K251781.

When was KALA MINI 2.0 (KALA-04) approved by the FDA?

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

What company makes KALA MINI 2.0 (KALA-04)?

KALA MINI 2.0 (KALA-04) is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd..

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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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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