The following data is part of a premarket notification filed by Silver Bay, Llc with the FDA for Quasar Blue Light Therapy System.
| Device ID | K093963 |
| 510k Number | K093963 |
| Device Name: | QUASAR BLUE LIGHT THERAPY SYSTEM |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | SILVER BAY, LLC 1431 Tallevast Road Sarasota, FL 34243 |
| Contact | Peter Nesbitt |
| Correspondent | Peter Nesbitt SILVER BAY, LLC 1431 Tallevast Road Sarasota, FL 34243 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-23 |
| Decision Date | 2010-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851478007110 | K093963 | 000 |
| 00851478007097 | K093963 | 000 |
| 00851478007080 | K093963 | 000 |
| 00851478007059 | K093963 | 000 |
| 00851478007042 | K093963 | 000 |