DeviceClearance

LED Light Therapy Machine (G1, G3, G4, G6)— 510(k) K242638

Substantially Equivalent

Shenzhen Walton Technology Co., Ltd.

FDA 510(k) clearance K242638 for LED Light Therapy Machine (G1, G3, G4, G6), Substantially Equivalent on 2024-11-27. Applicant: Shenzhen Walton Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant
Shenzhen Walton Technology Co., Ltd.
Product code
Code OHS
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shenzhen City, CN
Download summary PDFView on FDA.gov ↗

Recent devices under product code OHS

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Adverse events under product code OHS

product code OHS
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.