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Sculpt LED Belt (HY-150A +6 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K260688

by Shenzhen Kaiyan Medical Equipment Co, . Ltd

Identifiers

510(k) Number
K260688 FDA 510(k)
FDA Product Code
OLI FDA 510(k)
Models / Variants
HY-150A FDA 510(k)
HY-150B FDA 510(k)
HY-200A FDA 510(k)
HY-200B FDA 510(k)
HY-420A FDA 510(k)
HY-200D FDA 510(k)
HY-200C FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.5400 FDA 510(k)
Regulation Number
878.5400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Sculpt LED Belt (HY-150A +6 more) by Shenzhen Kaiyan Medical Equipment Co, . Ltd — Class II — FDA_510K — listed in FDA 510(k) — 7 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Kaiyan Medical Equipment Co, . Ltd
FDA Applicant
Shenzhen Kaiyan Medical Equipment Co., Ltd.

Sources (1)

  • FDA 510(k) K260688 24 fields · synced Jun 18, 2026