K232117
- 510(k) number
- K232117
- Device name
- Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)
- Applicant
- Wuhan Lotuxs Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2023-11-28
- Date received
- 2023-07-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K232117.pdf
Official FDA record: K232117
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.