510(k) K130225 ยท OHS Light Based Over The Counter Wrinkle Reduction
QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE
| Applicant | Silverbay, LLC, D/B/A Quasar Bio-Tech, Coralville IA, US |
| Decision | Substantially Equivalent, Jul 11, 2013 |
| Received | Jan 29, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130225
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2018 | Quasar Bio-Tech, Inc. Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device. Terminated |
OHS | None listed |
| Jun 29, 2018 | Quasar Bio-Tech, Inc. Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device. Terminated |
OHS | None listed |
| Jun 29, 2018 | Quasar Bio-Tech, Inc. Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device. Terminated |
OHS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.