Clearance Summary
UNFOLDER Vitan Inserter received FDA 510(k) clearance under submission number K191949, sponsored by Johnson & Johnson Surgical Vision, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2019-09-13.
- Submission: K191949
- Applicant / Sponsor: Johnson & Johnson Surgical Vision, Inc.
- Clearance pathway: Abbreviated
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2019-09-13
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.