Recall Z-2162-2020— Sonendo Inc

Name: FDA recall Z-2162-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-23

Class II · Terminated

Class II FDA medical device recall by Sonendo Inc, initiated 2019-10-23, terminated 2022-01-20. It names one FDA 510(k) clearance: K190359. Product: GENTLEWAVE REF: FG-002-0001. Reason: The console would continue to run for extended period when the foot pedal was released..

Recalling firm: Sonendo Inc
Classification: Class II
Status: Terminated
Initiated: 2019-10-23
Terminated: 2022-01-20
Firm location: Laguna Hills, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K190359 — Sonendo GentleWave SystemSonendo, Inc.·cleared 2019-03-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GENTLEWAVE REF: FG-002-0001

Reason for recall

The console would continue to run for extended period when the foot pedal was released.

Data sourced from openFDA. This site is unofficial and independent of the FDA.