Clearance Summary
INFRASCANNER received FDA 510(k) clearance under submission number K120949, sponsored by Infrascan, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2013-01-11.
- Submission: K120949
- Applicant / Sponsor: Infrascan, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 882.1935
- Decision date: 2013-01-11
Classification & Regulation
This clearance is catalogued under FDA product code OPT and 21 CFR 882.1935, within the Ophthalmic review panel as a Class II device.