FDA applicant

Carol Cole Company

Vista, CA6 decisions2007–20160 recalls

FDA records 6 decisions for Carol Cole Company (Vista, CA) from 2007 to 2016: 6 510(k) clearances. Most are in product codes NFO (Stimulator, Transcutaneous Electrical…) and OHS (Light Based Over The Counter Wrinkle Reduction). Its devices cite 8 predicates, 3 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, neurology panel, where it files most

How often FDA has decided Carol Cole Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Carol Cole Company’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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Other applicant names beginning “Carol”

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

Carol Cole Company Dba Nuface 8 Carol Block, Ltd. 1 Carol Wright Sales 1

Carol Cole Company

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?

Other applicant names beginning “Carol”