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510(k) K133752

SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT by Sonendo, Inc. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2014
Date Received
December 9, 2013
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.

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  • 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)
  • K130025 — SONENDO ENDOTHERAPY SYSTEM (June 11, 2013)

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