Clearance Summary
BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens received FDA 510(k) clearance under submission number K143280, sponsored by Brien Holden Vision Pty , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2015-04-23.
- Submission: K143280
- Applicant / Sponsor: Brien Holden Vision Pty , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2015-04-23
Classification & Regulation
This clearance is catalogued under FDA product code LPL and 21 CFR 886.5925, within the Ophthalmic review panel as a Class II device.