QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE— 510(k) K130225
Substantially EquivalentSilverbay, LLC, D/B/A Quasar Bio-Tech
FDA 510(k) clearance K130225 for QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE, Substantially Equivalent on 2013-07-11. Applicant: Silverbay, LLC, D/B/A Quasar Bio-Tech. Device class: 2.
Clearance details
- Applicant
- Silverbay, LLC, D/B/A Quasar Bio-Tech
- Product code
- Code OHS
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Coralville, IA, US
Recent devices under product code OHS
view allAdverse events under product code OHS
product code OHS- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K130225
K-number listed on FDA's recall record- Z-2973-2018 — Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
- Z-2974-2018 — Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
- Z-2975-2018 — Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130225.
Data sourced from openFDA. This site is unofficial and independent of the FDA.