Silver Bay, LLC
Laguna Niguel, CA, US
Silver Bay, LLC appears in FDA device records in Laguna Niguel, CA. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 5
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 5 510(k) clearances for Silver Bay, LLC between 2007 and 2012. The busiest year on record is 2010, with 2. The most recent is 2012, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2010 | 2 |
| 2012 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K112362 | C100 WRINKLE REDUCTION DEVICE | OHS | Substantially Equivalent | |
| K111286 | QUASAR CALYPSO | OLP | Substantially Equivalent | |
| K091467 | BABY QUASAR | ONE | Substantially Equivalent | |
| K093963 | QUASAR BLUE LIGHT THERAPY SYSTEM | OLP | Substantially Equivalent | |
| K072767 | QUASAR BLUE LIGHT THERAPY SYSTEM | GEX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain