FDA applicant

Carewear Corp.

Reno, NV1 decision2020–20200 recalls

FDA records 1 decision for Carewear Corp. (Reno, NV) in 2020: 1 510(k) clearance. All are in product code OHS (Light Based Over The Counter Wrinkle Reduction). 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, general and plastic surgery panel, where it files most

How often FDA has decided Carewear Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Carewear Corp. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Carewear Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Carewear Corp.

Which product codes does it file in?

What has FDA decided for it lately?