510(k) Report

FDA applicant

Lacrimedics, Inc.

Rosemead, CA12 decisions1985–20163 recalls

FDA records 12 decisions for Lacrimedics, Inc. (Rosemead, CA) from 1985 to 2016: 12 510(k) clearances. Most are in product codes LZU (Plug, Punctum) and HLJ (Ophthalmoscope, Battery-Powered). Its devices cite 2 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Lacrimedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2014: 12016: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2022

2014: 12022: 2
2007high 2 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Lacrimedics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lacrimedics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LZUPlug, Punctum10decisions
  • HLJOphthalmoscope, Battery-Powered1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K030300Opaque Herrick Lacrimal PlugLacrimedics, Inc. · 20033cite it
  • K895342Collagen Implants for the Lacrimal Efficiency TestLacrimedics, Inc. · 19893cite it
  • K896175Herrick Lacrimal Plug TM.Lacrimedics, Inc. · 19901cites it
  • K850649Absorbable Intracanalicular Collagen ImplantLacrimedics, Inc. · 19851cites it

What has FDA decided for it lately?

  • K161673LacriPro Punctum PlugLacrimedics, Inc. · 2016
  • K140026Collasyn Plug for the Lacrimal Efficiency TestLacrimedics, Inc. · 20141 recall
  • K030300Opaque Herrick Lacrimal PlugLacrimedics, Inc. · 2003
  • K021831Opaque Herrick Lacrimal Plug, 0.3MM,0.5MM,0.7MM, Models HLP3-Opb,HLP50OPB,HLP7-OpbLacrimedics, Inc. · 20021 recall
  • K001737Opaque Herrick Plug, 0.3MM; 0.5MM; O.7MMLacrimedics, Inc. · 2000
  • K963708Herrick Ultimate Punctum PlugLacrimedics, Inc. · 1997
  • K963501Herrick Ultimate Punctum PlugLacrimedics, Inc. · 1997
  • K944402FocometerLacrimedics, Inc. · 1994

All 12 as Lacrimedics, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K895342Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye…Jan 17, 2022Class II
  • K021831OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx…Jan 17, 2022Class II
  • K140026VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn…Nov 26, 2014Class III