510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Sonendo Inc

Laguna Hills, CA, US

SONENDO, INC. appears in FDA device records in Laguna Hills, CA. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
3
Registered establishments
1

510(k) clearance history

FDA records hold 9 510(k) clearances for Sonendo Inc between 2013 and 2021. The busiest year on record is 2016, with 2. The most recent is 2021, with 2.

Clearances by year, as a table
510(k) clearance decisions for Sonendo Inc, by decision year
YearClearances
20131
20141
20151
20162
20181
20191
20212
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K211995Sonendo Filling Material 5CKIFSubstantially Equivalent
K203302GentleWave XELCSubstantially Equivalent
K190359Sonendo GentleWave SystemELCSubstantially Equivalent
K181922Sonendo Material AKIFSubstantially Equivalent
K160905Sonendo GentleWave SystemELCSubstantially Equivalent
K153157Sonendo Gentle Wave SystemELCSubstantially Equivalent
K143448Sonendo GentleWave SystemELCSubstantially Equivalent
K133752SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KITELCSubstantially Equivalent
K130025SONENDO ENDOTHERAPY SYSTEMELCSubstantially Equivalent

Registered establishments

FDA registered establishments for Sonendo Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30108175213010817521SONENDO, INC.26061 Merit Circle, Laguna Hills, CA 92653 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0234-2023GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01Procedure Instruments with erroneous unit carton labels.Class IIOpen, Classified
Z-0233-2023GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02Procedure Instruments with erroneous unit carton labels.Class IIOpen, Classified
Z-2162-2020GENTLEWAVE REF: FG-002-0001The console would continue to run for extended period when the foot pedal was released.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain