510(k) Report

FDA applicant

Sun Capsule, Inc.

Danvers, MA2 decisions1987–20160 recalls

FDA records 2 decisions for Sun Capsule, Inc. (Danvers, MA) from 1987 to 2016: 2 510(k) clearances. Most are in product codes FTC (Light, Ultraviolet, Dermatological) and LEJ (Booth, Sun Tan). Its devices cite 1 predicate, 1 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, general and plastic surgery panel, where it files most

How often FDA has decided Sun Capsule, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sun Capsule, Inc.’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

Which product codes does it file in?

  • FTCLight, Ultraviolet, Dermatological1decision
  • LEJBooth, Sun Tan1decision

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K871237Sun Capsule I & II Suntanning BoothSun Capsule, Inc. · 19872cite it

What has FDA decided for it lately?

  • K152238Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5…Sun Capsule, Inc. · 2016
  • K871237Sun Capsule I & II Suntanning BoothSun Capsule, Inc. · 1987

All 2 as Sun Capsule, Inc. →