JOHN SGOMBICK

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30174004363017400436JOHN SGOMBICK1N2026-01-0137 Jeanne Dr Newburgh NY US 12550
30016445763001644576JOHN SGOMBICK1N2020-04-2537 JEANNE DRIVE, NEWBURGH, NY Newburgh NY US 12550

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2765441906658502K233782SmoothSkin Pure Adapt (SSG3)OHT2023-12-20
2765441343774486K230911Braun Skin i.expertOHT2023-04-27
2765441808658675K213692SmoothSkin Pure MiniOHT2022-01-26
2765441153133798K211994Braun Silk.expert MiniOHT2021-07-28
2765441711942731K200184SmoothSkin PureOHT2020-02-21
2765441208074003K192010SmoothSkin BARE+OHT2019-09-24
2765441043005833K190366BRAUN Silk Expert Pro 3OHT2019-03-18
2765441894226396K190354BRAUN Silk.expert Pro 5OHT2019-03-18
2077821504714874K170734Venus Silk.expertGEX2017-05-08
2077821972686938K162231iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expertOHT2016-11-16
2077821684464472K160968iPulse SmoothSkin Gold Hair Removal DeviceOHT2016-04-14
2077821625388232K143003iPulse Smooth Skin Gold Hair Removal SystemOHT2015-06-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OHT112023-12-20
GEX12017-05-08