K240118
- 510(k) number
- K240118
- Device name
- Picosecond Nd:YAG Laser System
- Applicant
- Smedtrum Medical Technology Co., Ltd. TW
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-04-30
- Date received
- 2024-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K240118.pdf
Official FDA record: K240118
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.