FDA applicant

Soft-Sert

Mchenry, IL1 decision1978–19780 recalls

FDA records 1 decision for Soft-Sert (Mchenry, IL) in 1978: 1 510(k) clearance. All are in product code KYE (Inserter/Remover Contact Lens). 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 Soft-Sert’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Soft-Sert since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Soft-Sert”

FDA records each applicant name separately; these may or may not be the same firm.

Soft-Core Texas, Inc. 2 Soft-Ray Optical Corp. 1 Soft Tissue Regeneration, Inc. 1

Soft-Sert

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Soft-Sert”