Neowise— 510(k) K260716
Substantially EquivalentCefla S.C.
FDA 510(k) clearance K260716 for Neowise, Substantially Equivalent on 2026-05-04. Applicant: Cefla S.C.. Device class: 2.
Clearance details
- Applicant
- Cefla S.C.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Imola (Bo), IT
Recent devices under product code LLZ
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- K213022 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.