The following data is part of a premarket notification filed by Silver Bay, Llc with the FDA for Quasar Calypso.
| Device ID | K111286 |
| 510k Number | K111286 |
| Device Name: | QUASAR CALYPSO |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | SILVER BAY, LLC 1131 ANTHEM VIEW LANE Knoxville, TN 37922 |
| Contact | Robert Wagner |
| Correspondent | Robert Wagner SILVER BAY, LLC 1131 ANTHEM VIEW LANE Knoxville, TN 37922 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-06 |
| Decision Date | 2012-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851478007219 | K111286 | 000 |
| 00851478007202 | K111286 | 000 |
| 00851478007196 | K111286 | 000 |