510(k) Report

FDA applicant

INTEROJO, Inc.

Pyeongtaek-Si, KR4 decisions2015–20260 recalls

FDA records 4 decisions for INTEROJO, Inc. (Pyeongtaek-Si, KR) from 2015 to 2026: 4 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Since 2016 its 510(k)s took a median of 101 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is 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 INTEROJO, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2015: 12016: 12022: 12026 (partial year): 1
2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — INTEROJO, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like INTEROJO, 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?

  • LPLLenses, Soft Contact, Daily Wear4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 101 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 112 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K153766Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft…INTEROJO, Inc. · 20164cite it
  • K221517POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact LensINTEROJO, Inc. · 20221cites it

What has FDA decided for it lately?

  • K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc. · 2026
  • K221517POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact LensINTEROJO, Inc. · 2022
  • K153766Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft…INTEROJO, Inc. · 2016
  • K142766I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily WearINTEROJO, Inc. · 2015

All 4 as INTEROJO, Inc. →