The following data is part of a premarket notification filed by Silver Bay, Llc with the FDA for C100 Wrinkle Reduction Device.
| Device ID | K112362 |
| 510k Number | K112362 |
| Device Name: | C100 WRINKLE REDUCTION DEVICE |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| 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 | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-17 |
| Decision Date | 2012-08-14 |
| Summary: | summary |