Chrysalis Intelligence · Sponsors · Reichert, Inc.

Reichert, Inc.

Depew, NY, US · 1 510(k) clearances · 3 recalls

Total clearances
1
2024-05-01 → 2024-05-01
Last 12 months
0
Product codes
1
Most recent
2024-05-01
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HKY 1 2024-05-01
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
3
Most recent
2025-02-28
DateSeverityStatusRecall # ProductCodeReason
2025-02-28 Class II Ongoing Z-1501-2025 Phoroptor VRx Digital Refraction System Model Numbers: 16242 The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
2025-02-28 Class II Ongoing Z-1500-2025 Phoroptor VRx Digital Refraction System Model Numbers: 16241 The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
2023-07-20 Class II Ongoing Z-2512-2023 PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive erro… Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthalmic stand. If the Phoroptor VRx Head detaches from the bracket,…
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2024-05-01 K233516 Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) HKY