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Femtosecond Laser System For Refractive Correction

FDA product code OTL · Class 3 · Unknown

7
Registered devices
74
Adverse events
1
Recalls
0
510(k) clearances

Devices with this code

VISUMAX — Carl Zeiss Meditec AGVisuMax — Carl Zeiss Meditec AGTreatment Pack (Type KP) — Carl Zeiss Meditec AGTreatment Pack (Size S) — Carl Zeiss Meditec AGTreatment Pack (Size M) — Carl Zeiss Meditec AGTreatment Pack (Size S) — Carl Zeiss Meditec AGTreatment Pack (Size L) — Carl Zeiss Meditec AG

Recent recalls

DateFirmReason
2018-12-06Carl Zeiss Meditec, Inc.VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss during tr

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.