Resonic 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 Resonic Rapid Acoustic Pulse Device.

Pre-market Notification Details

Device IDK212502
510k NumberK212502
Device Name:Resonic Rapid Acoustic Pulse Device
ClassificationPowered Laser Surgical Instrument
Applicant Soliton Inc. 5304 Ashbrook Drive Houston,  TX  77081
ContactLeslie Honda
CorrespondentJanice Hogan
Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia,  PA  19103
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-09
Decision Date2021-11-05

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