Lacrimedics Inc
FDA Regulatory Profile
Lacrimedics Inc appears in FDA public data with 3 recalls, 12 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0709-2022, Class II) was initiated on January 17, 2022. Its most recent 510(k) clearance was granted on November 18, 2016.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 12
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0709-2022 | Class II | Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment | January 17, 2022 |
| Z-0708-2022 | Class II | OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry ey | January 17, 2022 |
| Z-1081-2015 | Class III | VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model nu | November 26, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K161673 | LacriPro Punctum Plug | November 18, 2016 |
| K140026 | COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST | June 3, 2014 |
| K030300 | OPAQUE HERRICK LACRIMAL PLUG | May 9, 2003 |
| K021831 | OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB | July 1, 2002 |
| K001737 | OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM | June 19, 2000 |
| K963501 | HERRICK ULTIMATE PUNCTUM PLUG | April 14, 1997 |
| K963708 | HERRICK ULTIMATE PUNCTUM PLUG | April 14, 1997 |
| K944402 | FOCOMETER | November 22, 1994 |
| K896175 | HERRICK LACRIMAL PLUG TM. | January 22, 1990 |
| K895342 | COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST | November 2, 1989 |
| K890714 | LACRIMAL EFFICIENCY TEST (TM) | May 17, 1989 |
| K850649 | ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT | May 21, 1985 |