Lacrimedics, Inc.
Eastsound, WA, US
Lacrimedics, Inc. appears in FDA device records in Eastsound, WA. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Lacrimedics, Inc. between 1985 and 2016. The busiest year on record is 1989, with 2. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1989 | 2 |
| 1990 | 1 |
| 1994 | 1 |
| 1997 | 2 |
| 2000 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K161673 | LacriPro Punctum Plug | LZU | Substantially Equivalent | |
| K140026 | COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST | LZU | Substantially Equivalent | |
| K030300 | OPAQUE HERRICK LACRIMAL PLUG | LZU | Substantially Equivalent | |
| K021831 | OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB | LZU | Substantially Equivalent | |
| K001737 | OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM | LZU | Substantially Equivalent | |
| K963708 | HERRICK ULTIMATE PUNCTUM PLUG | LZU | Substantially Equivalent | |
| K963501 | HERRICK ULTIMATE PUNCTUM PLUG | LZU | Substantially Equivalent | |
| K944402 | FOCOMETER | HLJ | Substantially Equivalent | |
| K896175 | HERRICK LACRIMAL PLUG TM. | LZU | Substantially Equivalent | |
| K895342 | COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST | LZU | Substantially Equivalent | |
| K890714 | LACRIMAL EFFICIENCY TEST (TM) | LZU | Substantially Equivalent | |
| K850649 | ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0709-2022 | Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment | The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility. | Class II | Open, Classified | |
| Z-0708-2022 | OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment | The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility. | Class II | Open, Classified | |
| Z-1081-2015 | 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 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. Plugs are place in the upper and/or lower horizontal canaliculus. Two plugs are placed into a foam carrier and nitrogen sealed inside a foil pouch. The foil pouch is sent to sterilizer for gamma sterilization. Two sterile pouches are packaged in a box with an IFU. | Moisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon contact. The firm's data also suggests that a 4 year shelf life may not be sustained. | Class III | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain