510(k) Report

FDA applicant

Sunsoft Corp.

Albuquerque, NM2 decisions1995–19971 recall

FDA records 2 decisions for Sunsoft Corp. (Albuquerque, NM) from 1995 to 1997: 2 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). 1 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 Sunsoft Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sunsoft Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LPLLenses, Soft Contact, Daily Wear2decisions

What has FDA decided for it lately?

  • K964696Sunsoft (Methafilcon a) Soft (Hydrophilic) Daily Wear Contact LensSunsoft Corp. · 19971 recall
  • K942374Allure (Methafilcon a) Soft (Hydrophilic) Daily Wear Contact LensSunsoft Corp. · 1995

All 2 as Sunsoft Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K964696Sunsoft Multiples Toric, methafilcon A, clear contact lens.Dec 9, 2004