Red & Near Infrared LED Light Phototherapy Face Mask (Bway-FM01, Bway-FM02, Bway-FM03, Bway-FM05, Bway-FM06, Bway-FN01, Bway-E01, Bway-E02)— 510(k) K262984

Name: FDA 510(k) clearance K262984
Creator: U.S. Food and Drug Administration
Published: 2026-10-26

Substantially Equivalent

Shenzhen Bway Tech Co., Ltd.

FDA 510(k) clearance K262984 for Red & Near Infrared LED Light Phototherapy Face Mask (Bway-FM01, Bway-FM02, Bway-FM03, Bway-FM05, Bway-FM06, Bway-FN01, Bway-E01, Bway-E02), Substantially Equivalent on 2026-10-26. Applicant: Shenzhen Bway Tech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Bway Tech Co., Ltd.
Product code: Product code OHS
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2026-08-27
Decision date: 2026-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code OHS

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K262752 — Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9)2026-10-23
K262932 — AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3)2026-10-19
K260767 — Facial Beauty Device (Facial Mask LED Beauty Device A-901 +2 more2026-08-31
K261602 — Eye Recovery Pro (PH-e03)2026-08-10
K261601 — LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)2026-08-07

Adverse events under product code OHS

product code OHS

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.