Clearance Summary
NLITE SYSTEM, MODEL#: A00-1025/A00-1033 received FDA 510(k) clearance under submission number K024189, sponsored by Icn Photonics , 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 2003-06-20.
- Submission: K024189
- Applicant / Sponsor: Icn Photonics , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2003-06-20
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.