Theradome Inc

FDA Filings

This page includes the latest FDA filings for Theradome Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3008295459
FEI Number3008295459
NameTHERADOME, INC.
Owner & OperatorTheradome, Inc.
Contact Address4900 Hopyard Road Suite 100
Pleasanton CA 94588 US
Official Correspondent
  • Tamim S Hamid
  • 1-925-2649838-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4900 Hopyard Rd Ste 100
Pleasanton, CA 94588 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
Theradome, Inc.
 PRO LH80 PRO LH802020-12-10
Theradome, Inc.
 EVO LH40 EVO LH40 2020-12-10
Theradome, Inc.
Theradome LH402018-05-18
Theradome Inc.
Theradome LH80 PRO2018-01-09
THERADOME, INC.
LH40 EVO2016-06-07
Theradome, Inc
Laser Helmet LH40-EVO2016-05-12
THERADOME, INC.
LH80 PRO2015-03-26
THERADOME INC.
LASER HELMET2013-06-14
THERADOME INC.
LASER HELMET2012-03-02

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020041521482Hong Kong,Hong Kong -> Oakland, CaliforniaLITHIUM BATTERY60 CTN
2020040727096Hong Kong,Hong Kong -> Oakland, CaliforniaLITHIUM BATTERY50 CTN
2019090939012Yantian,China (Mainland) -> Oakland, CaliforniaACRYLIC DISPLAY50 CTN
2019062444114Yantian,China (Mainland) -> Oakland, CaliforniaFOAM PAD SETS14 CTN
2019060423179Hong Kong,Hong Kong -> Oakland, CaliforniaLITHIUM ION BATTERY23 CTN
2018101513706Yantian,China (Mainland) -> Oakland, CaliforniaNO WOOD PACKAGING MATERIAL IS USED IN THE S HIPMENT PLASTIC HELMET SPEAKER GASKET RE TAIL SLEEVES IFU QSG US AC ADAPTER FOAM P ADDING612 CTN
2018101515139Hong Kong,Hong Kong -> Oakland, CaliforniaLITHIUM ION BATTERY29 CTN
2018092235236Shanghai ,China (Mainland) -> Oakland, CaliforniaTHERADOME HELMET6 PKG
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