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Lacrimedics Inc

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
12
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0709-2022Class IICollagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatmentJanuary 17, 2022
Z-0708-2022Class IIOPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eyJanuary 17, 2022
Z-1081-2015Class IIIVisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model nuNovember 26, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K161673LacriPro Punctum PlugNovember 18, 2016
K140026COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TESTJune 3, 2014
K030300OPAQUE HERRICK LACRIMAL PLUGMay 9, 2003
K021831OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPBJuly 1, 2002
K001737OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MMJune 19, 2000
K963501HERRICK ULTIMATE PUNCTUM PLUGApril 14, 1997
K963708HERRICK ULTIMATE PUNCTUM PLUGApril 14, 1997
K944402FOCOMETERNovember 22, 1994
K896175HERRICK LACRIMAL PLUG TM.January 22, 1990
K895342COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TESTNovember 2, 1989
K890714LACRIMAL EFFICIENCY TEST (TM)May 17, 1989
K850649ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANTMay 21, 1985