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Gorgeous Beauty Equipment Manufacture Limited: FDA-registered device maker in Hong Kong, Hong Kong, 1 510(k) clearance

Name: Gorgeous Beauty Equipment Manufacture Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Gorgeous Beauty Equipment Manufacture Limited is registered with the FDA (registration 3043012074) in Hong Kong, Hong Kong. It lists 17 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 25, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3043012074
Address: Room 87, 1/F, Nanyang Centre, 75 Mody Road, Tsim Sha Tsui, Hong Kong, Hong Kong, 999077
Owner or operator: GORGEOUS BEAUTY EQUIPMENT MANUFACTURE LIMITED (10094575)
Roles: Contract manufacturer, Manufacturer
First device listed: December 8, 2025
Registered through: 2026
Brand names listed: 3D digital nail printer machine:MJY001,MJY002,MJY003,MJY004,MJY005,MJY006, Air pressure suit:AGF64,OMG61,OMG145,ksh68,OMG146,OMG147,OMG148,OMG149,OMG150,OMG-PST001,D03,OMD76,OM167,, BZY001,BZY002,BZY003,BZY004,BZY004,BZY005,BZY006,BZY007,BZY008,BZY009,BZY010,BZY011,, BZY012,BZY013,BZY014,BZY015,BZY016,BZY017,BZY018,BZY019,BZY020,BZY021,BZY022,BZY023,, BZY024,BZY025,BZY026,BZY027,BZY028,BZY029,BZY030,BZY031,BZY032,BZY033,BZY034,AG150,, Beauty bed/Chair:MRC001,MRC002,MRC003,MRC004,MRC006.MRC007, Body analyzer machine:C27,OM33,PFFX006,PFFX009,PFFX016, CLS0018,CLS0019,CLS0021,CLS30,CLS31,CLS32,CLS0033,CLS0037,CLS0038 and more

Devices it lists

Device	Product code	Class	Role	Source
Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase	DLI	1	Manufacturer	accessdata.fda.gov
Bed, Manual	FNJ	1	Manufacturer	accessdata.fda.gov
Calculator/Data Processing Module, For Clinical Use	JQP	1	Manufacturer	accessdata.fda.gov
Colonic Irrigation System	KPL	2	Manufacturer	accessdata.fda.gov
Device, Pressure Applying	KNM	1	Manufacturer	accessdata.fda.gov
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers	PZL	2	Manufacturer	accessdata.fda.gov
Gas, Laser Generating	NXF	1	Manufacturer	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Manufacturer	accessdata.fda.gov
High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation	SGN	2	Manufacturer	accessdata.fda.gov
Laser, Comb, Hair	OAP	2	Manufacturer	accessdata.fda.gov
Marker, Skin	FZZ	1	Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite	OUP	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Manufacturer	accessdata.fda.gov
Unit, Syringe, Air And/Or Water	ECB	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 25, 2024	K241860	Diode Laser Hair Removal System	GEX	Substantially Equivalent	Beijing Winkonlaser Technology Limited	accessdata.fda.gov

Compare with other makers

Updated September 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.