FDA applicant

Cl-Tinters

Colts Neck, NJ3 decisions1998–20010 recalls

FDA records 3 decisions for Cl-Tinters (Colts Neck, NJ) from 1998 to 2001: 3 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Its devices cite 2 predicates, 0 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 Cl-Tinters’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cl-Tinters since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Cl-Tinters

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?