Ulike Reglow Light Therapy Device (UM10)
K-Number: K260511 · 2026-03-16
Decision Date2026-03-16
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 2026-03-16 under approval number K260511. 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 2026-03-16. It is manufactured by Shenzhen Ulike Smart Electronics Co., Ltd.. The 510(k) number is K260511.
When was Ulike Reglow Light Therapy Device (UM10) approved by the FDA?
Ulike Reglow Light Therapy Device (UM10) received FDA 510(k) clearance on 2026-03-16, under approval number K260511.
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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