K243555
- 510(k) number
- K243555
- Device name
- LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)
- Applicant
- Shenzhen Eyco Technology Co., Ltd. CN
- Product code
- OLP — Over-The-Counter Powered Light Based Laser For Acne
- Decision date
- 2025-02-05
- Date received
- 2024-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243555.pdf
Official FDA record: K243555
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.