K242977
- 510(k) number
- K242977
- Device name
- 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
- Applicant
- Xuzhou Kernel Medical Equipment Co., Ltd. CN
- Product code
- FTC — Light, Ultraviolet, Dermatological
- Decision date
- 2025-02-06
- Date received
- 2024-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K242977.pdf
Official FDA record: K242977
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.