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510(k) K203302

GentleWave X by Sonendo, Inc. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2021
Date Received
November 9, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type

Other clearances by Sonendo, Inc.

  • K211995 — Sonendo Filling Material 5C (August 27, 2021)
  • K190359 — Sonendo GentleWave System (March 16, 2019)
  • K181922 — Sonendo Material A (October 22, 2018)
  • K160905 — Sonendo GentleWave System (June 3, 2016)
  • K153157 — Sonendo Gentle Wave System (January 29, 2016)
  • K143448 — Sonendo GentleWave System (May 1, 2015)
  • K133752 — SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE (May 15, 2014)
  • K130025 — SONENDO ENDOTHERAPY SYSTEM (June 11, 2013)

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