The following data is part of a premarket notification filed by Silverbay Llc, D/b/a Quasar Bio-tech with the FDA for Quasar C100, Baby Quasar Plus, Quasar Md Plus; Wrinkle Reduction Device.
| Device ID | K130225 |
| 510k Number | K130225 |
| Device Name: | QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | SILVERBAY LLC, D/B/A QUASAR BIO-TECH 2424DEMPSTER DRIVE Coralville, IA 52241 |
| Contact | Robert Wagner |
| Correspondent | Robert Wagner SILVERBAY LLC, D/B/A QUASAR BIO-TECH 2424DEMPSTER DRIVE Coralville, IA 52241 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-29 |
| Decision Date | 2013-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851478007103 | K130225 | 000 |
| 00851478007073 | K130225 | 000 |
| 00851478007066 | K130225 | 000 |
| 00851478007004 | K130225 | 000 |