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510(k) K153157

Sonendo Gentle Wave System by Sonendo, Inc. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2016
Date Received
November 2, 2015
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)
  • K190359 — Sonendo GentleWave System (March 16, 2019)
  • K181922 — Sonendo Material A (October 22, 2018)
  • K160905 — Sonendo GentleWave System (June 3, 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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