FDA-Device2022-11-23Class II
GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
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
15 instruments
Manufactured in
26051 Merit Cir Ste 104, N/A, Laguna Hills, CA, United States
Products
GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0233-2023Don't want to check this manually?
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