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Genesis Plus

CUTERA, INC. · Model Genesis Plus · UDI-DI 00816722021205

PDZGEX Prescription
10
510(k) clearances
3
Adverse events
1
Recalls
18
Facilities

Description

Genesis Plus Laser System

Recalls

DateFirmReason
2013-11-20Hyperion MedicalBrochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. The web site

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.