Clearance Summary
MOIRE FRINGE VISOMETER AFTER LOTMAR received FDA 510(k) clearance under submission number K800238, sponsored by Hagg-Streit Service, 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 1980-03-10.
- Submission: K800238
- Applicant / Sponsor: Hagg-Streit Service, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1780
- Decision date: 1980-03-10
Classification & Regulation
This clearance is catalogued under FDA product code HKL and 21 CFR 886.1780, within the Ophthalmic review panel as a Class II device.