510(k) Report

FDA applicant

Solarc Systems, Inc.

Barrie, Ontario, CA4 decisions1994–20110 recalls

FDA records 4 decisions for Solarc Systems, Inc. (Barrie, Ontario, CA) from 1994 to 2011: 4 510(k) clearances. All are in product code FTC (Light, Ultraviolet, Dermatological). Its devices cite 5 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Solarc Systems, 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, Dermatological4decisions

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K031800Solarc/Solrx 500 Series Ultraviolet Phototherapy Lamp Unit Family a New Medical Device Family Consisting of…Solarc Systems, Inc. · 20032cite it
  • K935572Solarc 1000 Series Ultraviolet Phototherapy Lamp UnitSolarc Systems, Inc. · 19941cites it
  • K061589Solarc / Solrx Handheld Ultraviolet Phototherapy Lamp Unit FamilySolarc Systems, Inc. · 20061cites it

What has FDA decided for it lately?

  • K103204Solarc / Solrx E-Series Ultraviolet Phototherapy Lamp Unit FamilySolarc Systems, Inc. · 2011
  • K061589Solarc / Solrx Handheld Ultraviolet Phototherapy Lamp Unit FamilySolarc Systems, Inc. · 2006
  • K031800Solarc/Solrx 500 Series Ultraviolet Phototherapy Lamp Unit Family a New Medical Device Family Consisting of…Solarc Systems, Inc. · 2003
  • K935572Solarc 1000 Series Ultraviolet Phototherapy Lamp UnitSolarc Systems, Inc. · 1994

All 4 as Solarc Systems, Inc. →