K241547
- 510(k) number
- K241547
- Device name
- Diode Laser Therapy Device (DF-DIODE LASER-S1)
- Applicant
- Weifang Dragonfly Electronics Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-08-13
- Date received
- 2024-05-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K241547.pdf
Official FDA record: K241547
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.