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FDA 510(k)

Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)

K-Number: K260688 · 2026-05-04

ApplicantShenzhen Kaiyan Medical Equipment Co., Ltd.
Decision Date2026-05-04
Product CodeOLI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) is a medical device manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-05-04 under approval number K260688. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)?

Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) is a medical device that received FDA 510(k) clearance on 2026-05-04. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K260688.

When was Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) approved by the FDA?

Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) received FDA 510(k) clearance on 2026-05-04, under approval number K260688.

What company makes Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)?

Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd..

What is the FDA product code for Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)?

The FDA product code for Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) is OLI.

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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