FDA applicant

Silver Bay, LLC

Knoxville, TN5 decisions2007–20120 recalls

FDA records 5 decisions for Silver Bay, LLC (Knoxville, TN) from 2007 to 2012: 5 510(k) clearances. Most are in product codes OLP (Over-The-Counter Powered Light Based Laser For…) and ONE (Powered Light Based Non-Laser Surgical…). Its devices cite 7 predicates, 2 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 Silver Bay, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2007high 2 (2010) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Silver Bay, LLC’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

Other applicant names beginning “Silver”

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

Silver Creek, Inc. 1 Silver Fox Corporation Limited 1 Silver Creek Surgical 1

Silver Bay, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Silver”