Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)— 510(k) K260688

Name: FDA 510(k) clearance K260688
Creator: U.S. Food and Drug Administration
Published: 2026-05-04

Substantially Equivalent

Shenzhen Kaiyan Medical Equipment Co., Ltd.

FDA 510(k) clearance K260688 for Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C), Substantially Equivalent on 2026-05-04. Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
Product code: Code OLI
Device class: Class 2
Regulation: 21 CFR 878.5400
Advisory panel: General, Plastic Surgery
Date received: 2026-03-03
Decision date: 2026-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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