K243085
- 510(k) number
- K243085
- Device name
- IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)
- Applicant
- Zhuzhou Goldenhot Medical Technology Co., Ltd. CN
- Product code
- OHT — Light Based Over-The-Counter Hair Removal
- Decision date
- 2024-12-21
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K243085.pdf
Official FDA record: K243085
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.