FTF

4 FDA 510(k) clearances · Product code

FDA profile

Official device name

Illuminator, Non-Remote

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4580

Medical specialty

General, Plastic Surgery

Flags

Third-party review eligible

Adverse events (MAUDE)

2001: 1 · 2002: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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