Reichert, Inc.
FDA Regulatory Profile
Reichert, Inc. appears in FDA public data with 3 recalls, 9 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1501-2025, Class II) was initiated on February 28, 2025. Its most recent 510(k) clearance was granted on May 1, 2024.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 9
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1501-2025 | Class II | Phoroptor VRx Digital Refraction System Model Numbers: 16242 | February 28, 2025 |
| Z-1500-2025 | Class II | Phoroptor VRx Digital Refraction System Model Numbers: 16241 | February 28, 2025 |
| Z-2512-2023 | Class II | PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of | July 20, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) | May 1, 2024 |
| K141954 | XCEL 455 SLIT LAMP | October 15, 2014 |
| K081756 | OCULAR RESPONSE ANALYZER | August 7, 2008 |
| K071839 | SOCT COPERNICUS, MODEL 15205 | February 27, 2008 |
| K070534 | MODIFICATION TO: OCU-FILM TIP COVER | March 27, 2007 |
| K063750 | XCEL 255 SLIT LAMP | December 20, 2006 |
| K061330 | PSL PORTABLE SLIT LAMP | May 25, 2006 |
| K042831 | ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER) | October 28, 2004 |
| K032799 | NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER | January 20, 2004 |