Company · US
Reichert, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2024. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 1, 2024 | K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) Reichert, Inc. | HKY |
| Oct 15, 2014 | K141954 | XCEL 455 SLIT LAMP Reichert, Inc. | HJO |
| Aug 7, 2008 | K081756 | OCULAR RESPONSE ANALYZER Reichert, Inc. | HKX |
| Feb 27, 2008 | K071839 | SOCT COPERNICUS, MODEL 15205 Reichert, Inc. | OBO |
| Mar 27, 2007 | K070534 | MODIFICATION TO: OCU-FILM TIP COVER Reichert, Inc. | HKY |
| Dec 20, 2006 | K063750 | XCEL 255 SLIT LAMP Reichert, Inc. | HJO |
| May 25, 2006 | K061330 | PSL PORTABLE SLIT LAMP Reichert, Inc. | HJO |
| Oct 28, 2004 | K042831 | ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER) Reichert, Inc. | IYO |
| Jan 20, 2004 | K032799 | NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER Reichert, Inc. | HKX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2025 | Reichert, Inc. Phoroptor VRx Digital Refraction System
Model Numbers: 16242 Open, Classified |
HKN | None listed |
| Mar 31, 2025 | Reichert, Inc. Phoroptor VRx Digital Refraction System
Model Numbers: 16241 Open, Classified |
HKN | None listed |
| Aug 31, 2023 | Reichert, Inc. PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye.
MODEL NUMBER: 16242
[Model 16241 is the base model. Model 16242 i Open, Classified |
HKN | None listed |