Clearance Summary
LightLas Pattern Scanning System - TruScan Pro received FDA 510(k) clearance under submission number K190448, sponsored by Light-Med(Usa), Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2019-05-24.
- Submission: K190448
- Applicant / Sponsor: Light-Med(Usa), Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 2019-05-24
Classification & Regulation
This clearance is catalogued under FDA product code HQF and 21 CFR 886.4390, within the Ophthalmic review panel as a Class II device.