Clearance Summary
NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 received FDA 510(k) clearance under submission number K003489, 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 2001-02-02.
- Submission: K003489
- 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: 2001-02-02
Classification & Regulation
This clearance is catalogued under FDA product code FSS and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.