Clearance Summary
VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System received FDA 510(k) clearance under submission number K210300, sponsored by Vuesonic, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2021-04-01.
- Submission: K210300
- Applicant / Sponsor: Vuesonic, LLC
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 2021-04-01
Classification & Regulation
This clearance is catalogued under FDA product code LYL and 21 CFR 886.5928, within the Ophthalmic review panel as a Class II device.