Ulike Clear Zero (YC10 BU)— 510(k) K260895
Substantially EquivalentGuangxi Ulike Medical Technology Co., Ltd.
FDA 510(k) clearance K260895 for Ulike Clear Zero (YC10 BU), Substantially Equivalent on 2026-05-28. Applicant: Guangxi Ulike Medical Technology Co., Ltd.. Device class: 2.
Summary
Guangxi Ulike Medical Technology's Ulike Clear Zero (YC10 BU) is filed under NFO, transcutaneous electrical stimulators for aesthetic purposes.
Class II, 21 CFR 882.5890. Neurology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Ulike filed from Yulin, China. The decision came 71 calendar days after receipt (March 18 to May 28, 2026).
Clearance details
- Applicant
- Guangxi Ulike Medical Technology Co., Ltd.
- Product code
- Product code NFO
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yulin, CN
Recent devices under product code NFO
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