Rapid Acoustic Pulse Device

Powered Laser Surgical Instrument

Soliton Inc.

The following data is part of a premarket notification filed by Soliton Inc. with the FDA for Rapid Acoustic Pulse Device.

Pre-market Notification Details

Device IDK201801
510k NumberK201801
Device Name:Rapid Acoustic Pulse Device
ClassificationPowered Laser Surgical Instrument
Applicant Soliton Inc. 5304 Ashbrook Drive Houston,  TX  77081
ContactLeslie Honda
CorrespondentJanice M Hogan
Hogan Lovells US LPP 1735 Market Street Suite 2300 Philadelphia,  PA  19103
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-30
Decision Date2021-01-29

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