Lacrimedics, Inc.
Lacrimedics, Inc. holds FDA 510(k) medical device clearances, first cleared 1985, most recent 2016, with 3 FDA device recalls on record.
Top product codes for Lacrimedics, Inc.
FDA recalls by Lacrimedics, Inc.
- Z-0709-2022 — Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
- 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
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Lacrimedics, Inc.
- K161673 — LacriPro Punctum Plug
- K140026 — COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
- K030300 — OPAQUE HERRICK LACRIMAL PLUG
- K021831 — OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB
- K001737 — OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM
- K963501 — HERRICK ULTIMATE PUNCTUM PLUG
- K963708 — HERRICK ULTIMATE PUNCTUM PLUG
- K944402 — FOCOMETER
- K896175 — HERRICK LACRIMAL PLUG TM.
- K895342 — COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST
- K890714 — LACRIMAL EFFICIENCY TEST (TM)
- K850649 — ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT
Data sourced from openFDA. This site is unofficial and independent of the FDA.