Clearance Summary
ISCREEN VISION SCREENER received FDA 510(k) clearance under submission number K102651, sponsored by Iscreen Vision, 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 2011-01-12.
- Submission: K102651
- Applicant / Sponsor: Iscreen Vision, Inc.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1120
- Decision date: 2011-01-12
Classification & Regulation
This clearance is catalogued under FDA product code HKI and 21 CFR 886.1120, within the Ophthalmic review panel as a Class II device.