Company ยท US
Lacrimedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2016. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 18, 2016 | K161673 | LacriPro Punctum Plug Lacrimedics, Inc. | LZU |
| Jun 3, 2014 | K140026 | COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST Lacrimedics, Inc. | LZU |
| May 9, 2003 | K030300 | OPAQUE HERRICK LACRIMAL PLUG Lacrimedics, Inc. | LZU |
| Jul 1, 2002 | K021831 | OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB Lacrimedics, Inc. | LZU |
| Jun 19, 2000 | K001737 | OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM Lacrimedics, Inc. | LZU |
| Apr 14, 1997 | K963708 | HERRICK ULTIMATE PUNCTUM PLUG Lacrimedics, Inc. | LZU |
| Apr 14, 1997 | K963501 | HERRICK ULTIMATE PUNCTUM PLUG Lacrimedics, Inc. | LZU |
| Nov 22, 1994 | K944402 | FOCOMETER Lacrimedics, Inc. | HLJ |
| Jan 22, 1990 | K896175 | HERRICK LACRIMAL PLUG TM. Lacrimedics, Inc. | LZU |
| Nov 2, 1989 | K895342 | COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST Lacrimedics, Inc. | LZU |
| May 17, 1989 | K890714 | LACRIMAL EFFICIENCY TEST (TM) Lacrimedics, Inc. | LZU |
| May 21, 1985 | K850649 | ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT Lacrimedics, Inc. |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2022 | Lacrimedics Inc Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE
Dry eye treatment Open, Classified |
LZU | K895342 |
| Jan 17, 2022 | Lacrimedics Inc OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE
Dry eye treatment Open, Classified |
LZU | K021831 |
| Feb 10, 2015 | Lacrimedics Inc VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905.
This device is cylindrical in shape, approximately 1.7 Terminated |
LZU | K140026 |