Clearance Summary
Bausch + Lomb PreVue Inserter for enVista Preloaded received FDA 510(k) clearance under submission number K192005, sponsored by Bausch & Lomb, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2019-10-04.
- Submission: K192005
- Applicant / Sponsor: Bausch & Lomb, Inc.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2019-10-04
Classification & Regulation
This clearance is catalogued under FDA product code MSS and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.