FDA applicant

Sola-Tan Intl.

Mchenry, IL3 decisions1984–19850 recalls

FDA records 3 decisions for Sola-Tan Intl. (Mchenry, IL) from 1984 to 1985: 3 510(k) clearances. All are in product code FTC (Light, Ultraviolet, Dermatological). 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 Sola-Tan Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sola-Tan Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sola-Tan Intl.’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 “Sola-Tan”

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

Sola Medical Devices, LLC 1 Sola Ophthalmics 1 Sola-Syntex Ophthalmics 1

Sola-Tan Intl.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Sola-Tan”