Reichert, Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
9
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1501-2025Class IIPhoroptor VRx Digital Refraction System Model Numbers: 16242February 28, 2025
Z-1500-2025Class IIPhoroptor VRx Digital Refraction System Model Numbers: 16241February 28, 2025
Z-2512-2023Class IIPHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement ofJuly 20, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)May 1, 2024
K141954XCEL 455 SLIT LAMPOctober 15, 2014
K081756OCULAR RESPONSE ANALYZERAugust 7, 2008
K071839SOCT COPERNICUS, MODEL 15205February 27, 2008
K070534MODIFICATION TO: OCU-FILM TIP COVERMarch 27, 2007
K063750XCEL 255 SLIT LAMPDecember 20, 2006
K061330PSL PORTABLE SLIT LAMPMay 25, 2006
K042831ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER)October 28, 2004
K032799NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZERJanuary 20, 2004