FDA-Device2022-11-23Class II

GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01

Sonendo Inc

Hazard

Procedure Instruments with erroneous unit carton labels.

Sold states

Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.

Affected count

16 instruments

Manufactured in

26051 Merit Cir Ste 104, N/A, Laguna Hills, CA, United States

Products

GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0234-2023

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