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510(k) K190359

Sonendo GentleWave System by Sonendo, Inc. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2019
Date Received
February 15, 2019
Clearance Type
Special
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)
  • K203302 — GentleWave X (February 5, 2021)
  • 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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