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FDA 510(k)

KALA Therapy Wand (Model: KALA-03)

K-Number: K250761 · 2025-07-11

ApplicantShenzhen Kaiyan Medical Equipment Co., Ltd.
Decision Date2025-07-11
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KALA Therapy Wand (Model: KALA-03) is a medical device manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-07-11 under approval number K250761. 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 Therapy Wand (Model: KALA-03)?

KALA Therapy Wand (Model: KALA-03) is a medical device that received FDA 510(k) clearance on 2025-07-11. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K250761.

When was KALA Therapy Wand (Model: KALA-03) approved by the FDA?

KALA Therapy Wand (Model: KALA-03) received FDA 510(k) clearance on 2025-07-11, under approval number K250761.

What company makes KALA Therapy Wand (Model: KALA-03)?

KALA Therapy Wand (Model: KALA-03) is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd..

What is the FDA product code for KALA Therapy Wand (Model: KALA-03)?

The FDA product code for KALA Therapy Wand (Model: KALA-03) 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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