FDA 510(k)

Ulike Reglow Light Therapy Device (UM10)

K-Number: K243492 · 2025-01-10

ApplicantShenzhen Ulike Smart Electronics Co., Ltd.

Decision Date2025-01-10

Product CodeOHS

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Ulike Reglow Light Therapy Device (UM10) is a medical device manufactured by Shenzhen Ulike Smart Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-01-10 under approval number K243492. 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 Ulike Reglow Light Therapy Device (UM10)?

Ulike Reglow Light Therapy Device (UM10) is a medical device that received FDA 510(k) clearance on 2025-01-10. It is manufactured by Shenzhen Ulike Smart Electronics Co., Ltd.. The 510(k) number is K243492.

When was Ulike Reglow Light Therapy Device (UM10) approved by the FDA?

Ulike Reglow Light Therapy Device (UM10) received FDA 510(k) clearance on 2025-01-10, under approval number K243492.

What company makes Ulike Reglow Light Therapy Device (UM10)?

Ulike Reglow Light Therapy Device (UM10) is manufactured by Shenzhen Ulike Smart Electronics Co., Ltd..

What is the FDA product code for Ulike Reglow Light Therapy Device (UM10)?

The FDA product code for Ulike Reglow Light Therapy Device (UM10) is OHS.

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Official Source

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