FDA.report

510(k) K254220

Device
Reusable 3 Button Fingerswitch Wand
Applicant
Soniquence, LLC
510(k) number
K254220
Product code
GEI
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-27
Date received
2025-12-29
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Suzanne Lucas
Address
2477 Grand Ave. Baldwin NY US 11510 11510

FDA Registration Numbers

Source Documents

510(k) summary PDF

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