510(k) Report

FDA applicant

Silverbay, LLC, D/B/A Quasar Bio-Tech

Coralville, IA1 decision2013–20133 recalls

FDA records 1 decision for Silverbay, LLC, D/B/A Quasar Bio-Tech (Coralville, IA) in 2013: 1 510(k) clearance. All are in product code OHS (Light Based Over The Counter Wrinkle Reduction). 3 recalls are 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 Silverbay, LLC, D/B/A Quasar Bio-Tech’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

3in 2018

2018: 3
2013high 3 (2018) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Silverbay, LLC, D/B/A Quasar Bio-Tech by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OHSLight Based Over The Counter Wrinkle Reduction1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K130225Quasar C100, Baby Quasar Plus, Quasar MD Plus; Wrinkle Reduction DeviceSilverbay, LLC, D/B/A Quasar Bio-Tech · 20132cite it

What has FDA decided for it lately?

  • K130225Quasar C100, Baby Quasar Plus, Quasar MD Plus; Wrinkle Reduction DeviceSilverbay, LLC, D/B/A Quasar Bio-Tech · 20133 recalls

The one decision as Silverbay, LLC, D/B/A Quasar Bio-Tech →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K130225Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld…Jun 29, 2018Class II
  • K130225Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld…Jun 29, 2018Class II
  • K130225Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld…Jun 29, 2018Class II