FDA.reportPublic FDA data

THERADOME, INC.

Matched from indexed company URL: THERADOME INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30082954593008295459THERADOME, INC.1N2026-01-011000 N West St Ste 1200 Wilmington DE US 19801

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B399EVO0400EVO LH40 - Theradome EVO LH40 laser helmet is a low level laser therapy (LLLT) devices containing red, visible light diode lasers operating at 678 nanometers, designed to deliver non-thermal energy to the hair follicles used to promote hair growth via photobiostimulation of the scalp.1-855-549-6757support@theradome.com
B399PRO0800PRO LH80 - Theradome PRO LH80 laser helmet is a low level laser therapy (LLT) device containing red, visible light diode lasers operating at 678 nanometers, designed to deliver non-thermal energy to the hair follicles used to promote hair growth via photobiostimultion of the scalp.1-855-549-6757support@theradome.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1814772023802151K161046Laser Helmet LH40-EVOOAP2016-05-12
1814771818178251K122950LASER HELMETOAP2013-06-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OAP42016-05-12

PMN#

GUDID#