Silver Bay, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Silver Bay, LLC” (first 2007, latest 2012), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 257 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 310 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLP | Over-The-Counter Powered Light Based Laser For Acne | 2 | 2 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| OHS | Light Based Over The Counter Wrinkle Reduction | 1 | 1 |
| ONE | Powered Light Based Non-Laser Surgical Instrument | 1 | 1 |
Review panels
Most recent Silver Bay, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112362 | C100 WRINKLE REDUCTION DEVICE | OHS | 2012-08-14 | 363 |
| K111286 | QUASAR CALYPSO | OLP | 2012-01-18 | 257 |
| K091467 | BABY QUASAR | ONE | 2010-09-17 | 487 |
| K093963 | QUASAR BLUE LIGHT THERAPY SYSTEM | OLP | 2010-08-27 | 247 |
| K072767 | QUASAR BLUE LIGHT THERAPY SYSTEM | GEX | 2007-10-15 | 17 |
Recalls
openFDA lists no recalls under a recalling firm named Silver Bay, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Silver Creek, Inc. (1 510(k)s)
- Silver Creek Surgical (1 510(k)s)
- Silver Fox Corporation Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Silver Bay, LLC?
FDA lists 5 510(k) clearances under the applicant name “Silver Bay, LLC” (first 2007, latest 2012), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Silver Bay, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Silver Bay, LLC is 257 days.
Which FDA product codes appear under Silver Bay, LLC?
The most frequent FDA product codes under this applicant name are OLP (Over-The-Counter Powered Light Based Laser For Acne, 2); GEX (Powered Laser Surgical Instrument, 1); OHS (Light Based Over The Counter Wrinkle Reduction, 1).
Next steps
- See all 5 Silver Bay, LLC clearances with predicates and recalls
- Run predicate analysis for product code OLP, Silver Bay, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.