FDA.reportPublic FDA data

BOMTECH ELECTRONICS CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30070478893007047889BOMTECH ELECTRONICS CO., LTD.1N2026-01-01322, Gonghang-daero, Gangseo-gu, Seoul KR 07646

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
08800016000436RM STAR EX with RMS Needle - The RM STAR EX with RMS Needle is intended for use in dermatologic procedures for electrocoagulation and hemostasis.+8225238295bomtech@bomtech.net
08800016000443E-PEN - The E-PEN is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older.+8225238295bomtech@bomtech.net

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1351741660071444K243143E-PEN (E-PEN)QAI2025-04-07
1351741674216485K243097RM STAR EX with RMS NeedleGEI2024-12-26
1351741573132215
1351741650470516
1351741870133135
1351742065271776

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI22024-12-26
QAI12025-04-07

PMN#

GUDID#