LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)— 510(k) K243555

Substantially Equivalent

Shenzhen Eyco Technology Co., Ltd.

FDA 510(k) clearance K243555 for LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A), Substantially Equivalent on 2025-02-05. Applicant: Shenzhen Eyco Technology Co., Ltd..

Clearance details

Applicant
Shenzhen Eyco Technology Co., Ltd.
Product code
Code OLP
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Guangdong, CN
Download summary PDFView on FDA.gov ↗

Adverse events under product code OLP

product code OLP
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.