Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043654467

FEI Number

3043654467

Entity Name

CHANGSHA GOMECY ELECTRONICS CO., LTD.

City/State/Country

Changsha Hunan, CN

Establishment Address

Room 2501, Building 11, Dangdai Binjiangyuan, No. 125 Hanguang Road, Guanshalin Street, Yuelu District,, Changsha Hunan 410000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Changsha GOMECY Electronics Co., Ltd. (Owner Number: 10094986)

Owner / Operator Contact Address

Room 2501, Building 11, Dangdai Binjiangyuan, No. 125 Hanguang Road, Guanshalin Street, Yuelu District,, Changsha, CN-HN 410000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Plasma Machine:GMS PM 01, GMS PM 02, GMS PM 03, GMS PM 04, GMS PM 05. GMS A59, GMS B59 Cryolipolysis Slimming Machine:GMS 360 Cryo P03, GMS 360 Cryo P04 Laser Multifunctional Machine:GMS-M01, GMS-M02, GMS-M03, GMS-M04, GMS-M05 Hair Removal Machine:Glory, Faery, K8, K9, K10, K11, K16, K17, K18, 808-A, 808-B,808-C,808-D,808-E,808-H, 808-M Pico Laser Tattoo Removal :Picory, PicoNova, GMS260, GMS280, GMS580, GMS-Q5, GMS-Q6, GMS-Q7, GMS-Q8 Q-switched Nd:Yag Laser Machine:GMS-Q1, GMS-Q2, GMS-Q3, GMS-Q4, GMS-Q5, GMS-Q6, GMS-Q7 Co2 Fractional Laser:GMS-C1, GMS-C2, GMS-C3, GMS-C4, GMS-C5, GMS-C6 PMS PMST 3 Neo, PMST 4 Neo, PMST 1Neo+, PMST2Neo+, PMST 3NeO+, PMST 4Neo+, PMSTWAVE, PMST WAVE NEO+, PMST 687, PMST 682, GMS IP 50,GMS IP 1064, GMS IP 20, PSW 01, PSW02, ESW01, ESW 03, EMSW 01, EM-F, ULSW01, ESWT Double C, Physiotherapy Machine:PMST2, PMST3, PMST4, PMST1NeO, PMST2Neo, Panacea01, Panacea 02, Panacea 650,10D Luxmaster, PMST MAX, PMST DUO MAX, PMST LOOP, PMST LOOP PRO, PMST LOOP PRO MAX, PMST+6D, ESWT-GMS-B Pro, ESWT Double B,Tecar O1,Tecar Tecar 03,Tecar ProTecar Pro+Tecar BAT 3S+, A63, B63, A69, SW7 Hydra Dermabrasion Machine:H5020, H5021, SPA01, SPA02, WA16, W05X 3 & 4 IPL SHR Machine:Faery, GMS-P1, GMS-P2, GMS-P3, GMS-P4, GMS-P5 Emslim Machine:139A,1139B,1139C,1139D,1139E,1139F,1139G,1139H,1139I,1139J, 1139K,1139L,1139M,1139N,1139A+RF,1139B+RF,1139C+RF, 1139D+RF,1139E+RF,1139F+RF,1139G+RF,1139H+RF, 11391+RF, 1139J+RF, 1139L+RF Lipo Laser Slimming Machine:6D P01, 6D P02, 6D V01 Micro-needles RF Machine:GMS-H1, GMS-H2, GMS-H3, GMS-H4, GMS-H5, GMS-H6, GMS-H7, GMS-A2, GMS-A27 GMS-M8 VelaShape Slimming Machine:GMS-VE8, GMS-VE9, GMS-VE10, GMS-VE10 Pro, GMS-VE11, GMS-VEP8, GMS-VEP9, GMS-V9, GMS-V10, GMS 360 Cryo P01, GMS 360 Cryo P02

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JER	Cleaner, Denture, Mechanical	Dental	Class 1	872.3530	2026-01-12
NXF	Gas, Laser Generating	General, Plastic Surgery	Class 1	878.4810	2026-01-12
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2026-01-12
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2026-01-12
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2026-01-12
KNM	Device, Pressure Applying	Physical Medicine	Class 1	890.5765	2026-01-12
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2026-01-12

Official Correspondent

Meiling Wang

US Agent Details

Jame Chen Email: ssgxcfe@outlook.com Phone: (805) 3513025

Related Public Records

Same Entity

Changsha GOMECY Electronics Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043654467. Last updated year: 2026. Please use registration number 3043654467 when referencing this establishment in official correspondence.