Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043012074

FEI Number

3043012074

Entity Name

GORGEOUS BEAUTY EQUIPMENT MANUFACTURE LIMITED

City/State/Country

Hong Kong, HK

Establishment Address

Room 87, 1/F, Nanyang Centre, 75 Mody Road, Tsim Sha Tsui,, Hong Kong 999077, HK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GORGEOUS BEAUTY EQUIPMENT MANUFACTURE LIMITED (Owner Number: 10094575)

Owner / Operator Contact Address

Room 87, 1/F, Nanyang Centre, 75 Mody Road, Tsim Sha Tsui,, Hong Kong, HK-NOTA 999077, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ELECTRONIC MUSCLE STIMULATOR Omg25,Omg57,Omg68,Omg69,Omg89,Omg99,Omg120,Omg139,Omg140,Omg142,Omg158,Omg170,Omg197,Omg203, Omg205,Omg209,Omg213,Omg215,JXY-SYY001,JXY-SYY002,JXY-SYY003,JXY-SYY004, Facial Spa Oxygen Hydro Facial Beauty System:AG51,AG154,AGF04,AGF54,AGF55,AGF68,AMB53,Keysun160,ksh75,Omd85, Hyperbaric Oxygen Chamber Spa capsule:OMG-TKC009,OMG-TCK011,JXY-GYYC001 Body analyzer machine:C27,OM33,PFFX006,PFFX009,PFFX016 JXY-SYY005,JXY-SYY006,JXY-SYY007, XOM-SYY001,YTL-SYY001,YTL-SYY002,YTL-SYY003 Diode Laser Hair Removal System CLS0018,CLS0019,CLS0021,CLS30,CLS31,CLS32,CLS0033,CLS0037,CLS0038 Muscle Stimulation EMS Sculpting Machines:AME83,KSH64,OMG127,OMG128,OMG129,OMG174,CLS0017, OMG198,OMG211,OMG217,OMG219,HF001,HF002,HF003,HF004,HF005,OMG193,HF006,HF0022, HF0017,HF0021,HF0026,HF007,HF008,HF0023,HF009,HF0010,HF0011,HF0012,HF0013,HF0014,OMG135, HF0034,HF0035,HF0036,HF0037,HF0038,HF0039,HF0040,HF0041,HF0042,HF0043 OMG131,OMG165,OMG210,OMG166,OMG167,OMG177,OMG191,OMG206,HF0030,OMG207,OMG199, High Intensity Focused Ultrasound System:OM18,OM32 ,OMD04,OMF71,OME72,OM121,OM120,OM140,OMG77,OMG79,OMG108,OMG114, HF0016,HF0018,HF0019,HF0020,HF0024,HF0025,AGF65,HF0028,HF0029,HF0031,HF0032,HF0033, CO2 OMG-PST002,OMG-PST003,OMG-QYF0013,XOM-QYF001 Air pressure suit:AGF64,OMG61,OMG145,ksh68,OMG146,OMG147,OMG148,OMG149,OMG150,OMG-PST001,D03,OMD76,OM167, OMG178, OMG179, OMG181, OMG214, OMG218, TMY001, TMY002, TMY003, TMY004, TMY005, TMY006, TMY007, TMY008, TMY009, Diode Laser Hair Removal System:AG108, AME50, OM101, OMG32, OMG121, OMG132, OMG134, OMG137, OMG138, TMY025, TMY026, TMY027, TMY028, TMY029, TMY030, TMY031, TMY032, TMY033, TMY034, TMY035, TMY036, TMY037, TMY038, TMY039, XOM-TMY002, XOM-TMY003 Multi-functional 980 1470 Diode Laser Machine:LLY006, LLY007, LLY008 ,LLY0030,LLY0043, OM213 TMY040, TMY041, TMY042, TMY043, TMY044, JXY-TMY001, JXY-TMY002, JXY-TMY003, JXY-TMY004, JXY-TMY005, XOM-TMY001, TMY010, TMY011, TMY012, TMY013, TMY014, TMY015, TMY016, TMY017, TMY018, TMY019, TMY020, TMY021, TMY022, TMY023, TMY024, 3D digital nail printer machine:MJY001,MJY002,MJY003,MJY004,MJY005,MJY006 colon hydrotherapy machine:YL001,YL002,YL003,YL004,YL005,YL006,YL007 EMS face:CLS0025,CLS0026,CLS0027,CLS0028,CLS0029,CLS0030,CLS0031,CLS0032,CLS0033,CLS0034,CLS0035 Plasma Beauty device :LZB001,LZB002,LZB003,LZB004,LZB005,LZB006,LZB007,LZB008,LZB009,LZB010 Laser slimming machine:OMG103, OMG115, OMG152, OMG169, JGJF001, JGJF002, JGJF003, JGJF004, JGJF005, JGJF0015, JGJF0016, JGJF0017, JGJF0018, JXY-JGJF001, XOM-JGJF001, XOM-JGJF002 JGJF006, JGJF007, JGJF008, JGJF009, JGJF0010, JGJF0011, JGJF0012, JGJF0013, JGJF0014, Skin analyzer machine:KSH75,PFFX001,PFFX002,PFFX005,OM26,PFFX005,PFFX008,PFFX0011,PFFX0014 DZ019, DZ010, DZ021, DZ027, DZ030, DZ031, DZ032, DZ033, DZ034, DZ035, DZ036, DZ037 Fractional CO2 Laser System Machine:AGF80, AME85, DZ001, DZ008, DZ009, DZ010, DZ012, DZ013, DZ014, DZ015, DZ016, DZ018,

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2025-12-09
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2025-12-08
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-12-08
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2025-12-08
SGN	High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation	Neurology	Class 2	882.4420	2025-12-08
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-12-08
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2025-12-09
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-12-08
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2025-12-09
KPL	Colonic Irrigation System	Gastroenterology, Urology	Class 2	876.5220	2025-12-09
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2025-12-08
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2025-12-08
DLI	Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase	Clinical Toxicology	Class 1	862.3240	2025-12-08

Official Correspondent

Shujuan Zhao

US Agent Details

Wilson Li Business: REPF America LLC Email: qagujdsvvt@outlook.com Phone: (719) 2013315

Related Public Records

Same Entity

GORGEOUS BEAUTY EQUIPMENT MANUFACTURE LIMITED

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03
K820884	Nitron Electronics	ELECTRICAL MUSCLE STIMULATOR	1982-04-29
K201958	Therasigma, LLC	ETD Family of Electrotherapy Devices	2020-08-04
K964028	Mettler Electronics Corp.	SYS STIM 226	1997-02-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0007-04	Misys Healthcare Systems	1	Calculator/Data Processing Module for Clinical Use
Z-0026-2025	Becton Dickinson & Co.	1	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

Similar Registrations

Registration Number	Establishment Name	Location
3020683829	SUZHOU FAST ATM ELECTRIC CO., LTD	Suzhou Jiangsu, CN
3005344585	ODSTOCK MEDICAL LTD	SALISBURY Wiltshire, GB
3038295706	JUST KEEP HEALTHY CO., LTD.	Samkkei Munichay District Kampong Speu, KH
3019892999	CIONIC Facility	Scotts Valley, CA, US
3012316249	COMPASS HEALTH BRANDS (CORPORATE OFFICE)	Middleburg Heights, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043012074. Last updated year: 2026. Please use registration number 3043012074 when referencing this establishment in official correspondence.