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LED Light Therapy Face Mask (FM60X +8 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K253400

by Shenzhen Saidi Light Therapy Technology Co., Ltd.

Identifiers

510(k) Number
K253400 FDA 510(k)
FDA Product Code
OHS FDA 510(k)
Models / Variants
FM60X FDA 510(k)
FM60X-B FDA 510(k)
FM60X-W FDA 510(k)
FM80-W FDA 510(k)
FM80 FDA 510(k)
VAP1 FDA 510(k)
FM100X FDA 510(k)
FM100X-B FDA 510(k)
FM100X-W FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

LED Light Therapy Face Mask (FM60X +8 more) by Shenzhen Saidi Light Therapy Technology Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 9 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Saidi Light Therapy Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K253400 24 fields · synced Jun 18, 2026