K253219
- 510(k) number
- K253219
- Device name
- LeafPure-Echo (LM-LPNdA)
- Applicant
- Shenzhen Leaflife Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-11-25
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K253219
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.