Clearance Summary
Q-LUX PLASMA 100 LIGHT CURE UNIT received FDA 510(k) clearance under submission number K001719, sponsored by Rolence Enterprise Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-10-10.
- Submission: K001719
- Applicant / Sponsor: Rolence Enterprise Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6070
- Decision date: 2000-10-10
Classification & Regulation
This clearance is catalogued under FDA product code EBZ and 21 CFR 872.6070, within the Dental review panel as a Class II device.