ULTRA RENEW PLUS— 510(k) K132833
Substantially EquivalentAccord Media
FDA 510(k) clearance K132833 for ULTRA RENEW PLUS, Substantially Equivalent on 2014-06-17. Applicant: Accord Media. Device class: 2.
Clearance details
- Applicant
- Accord Media
- Product code
- Code OLP
- 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
- Los Gatos, CA, US
Recent devices under product code OLP
view allAdverse events under product code OLP
product code OLP- 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 K132833
K-number listed on FDA's recall record- Z-0819-2018 — Ultra Renew
- Z-0820-2018 — Truth Renew
- Z-0821-2018 — Ultra Renew Plus
- Z-0822-2018 — Truth Renew Plus
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132833.
Data sourced from openFDA. This site is unofficial and independent of the FDA.