K242068
- 510(k) number
- K242068
- Device name
- LED Light Therapy Mask (RT01)
- Applicant
- Ningbo Dechang Electrical Machinery Made Co.,Ltd CN
- Product code
- OLP — Over-The-Counter Powered Light Based Laser For Acne
- Decision date
- 2025-04-04
- Date received
- 2024-07-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242068.pdf
Official FDA record: K242068
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.