K251076
- 510(k) number
- K251076
- Device name
- Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)
- Applicant
- Shenzhen Lifotronic Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-07-30
- Date received
- 2025-04-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.4 MB · U.S. public domain
Also available from FDA: K251076.pdf
Official FDA record: K251076
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.