Clearance Summary
LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES received FDA 510(k) clearance under submission number K053227, sponsored by Medical Illumination International, Inc.. 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 2006-01-13.
- Submission: K053227
- Applicant / Sponsor: Medical Illumination International, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 2006-01-13
Classification & Regulation
This clearance is catalogued under FDA product code FST and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.