← Back to catalogue

LED Light Therapy Mask - Chin2Chest

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250830

by Shenzhen Sungrow LED Technology Co., LTD

Identifiers

510(k) Number
K250830 FDA 510(k)
FDA Product Code
OHS FDA 510(k)
Models / Variants
G15 FDA 510(k)
G15P FDA 510(k)
G15K FDA 510(k)
G11P FDA 510(k)
G11 FDA 510(k)
G10 FDA 510(k)
G13 FDA 510(k)
G14 FDA 510(k)
G17 FDA 510(k)
VISO FDA 510(k)
PRANA FDA 510(k)
Chin2Chest FDA 510(k)
BBL-FACEMASK 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 Mask - Chin2Chest by Shenzhen Sungrow LED Technology Co., LTD — Class II — FDA_510K — listed in FDA 510(k) — 13 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shenzhen Sungrow LED Technology Co., LTD
FDA Applicant
Shenzhen Sungrow Led Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K250830 24 fields · synced Jun 18, 2026