Phakos

FDA Regulatory Profile

Phakos appears in FDA public data with 0 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on June 2, 2020.

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K200911MIRA AdapterJune 2, 2020
K173944Endocular Viewing Lenses and Silicone RingOctober 25, 2018
K180195Frigitronics adapterMarch 16, 2018
K162756PHAKOS Disposable Retinal Cryo ProbeMay 3, 2017