Clearance Summary
Intense Pulsed Light Treatment System (LK-PT) received FDA 510(k) clearance under submission number K242440, sponsored by Nanjing Bestview Laser S&T Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-11-14.
- Submission: K242440
- Applicant / Sponsor: Nanjing Bestview Laser S&T Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2024-11-14
Classification & Regulation
This clearance is catalogued under FDA product code ONF and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.