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 IDK200331
510k NumberK200331
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 Levells US LLP 1735 Market Street, Suite 2300 Philadelphia,  PA  19103
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-10
Decision Date2020-03-10

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