Clearance Summary
Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT received FDA 510(k) clearance under submission number K980793, 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 1998-05-15.
- Submission: K980793
- Applicant / Sponsor: Rolence Enterprise Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 1998-05-15
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.