Clearance Summary
DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD received FDA 510(k) clearance under submission number K042382, sponsored by Med-General Technologies, LLC. 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 2004-11-30.
- Submission: K042382
- Applicant / Sponsor: Med-General Technologies, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 2004-11-30
Classification & Regulation
This clearance is catalogued under FDA product code FSY and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.