Clearance Summary
LYSTA LC CURING LIGHT, MODEL LC 2500C/BA received FDA 510(k) clearance under submission number K991138, sponsored by Lysta A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1999-04-23.
- Submission: K991138
- Applicant / Sponsor: Lysta A/S
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6070
- Decision date: 1999-04-23
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.