OMAN MEDICAL BEAUTY MANUFACTURE LIMITED

FDA Device Registration & Listing · Hong Kong, HK · Registration 3042228064

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3042228064
FEI Number
3042228064
Entity Name
OMAN MEDICAL BEAUTY MANUFACTURE LIMITED
City/State/Country
Hong Kong, HK
Establishment Address
Room B, 17/F, Run Kee Commercial Building, 680-682 Shanghai Street, Mong Kok, Hong Kong 999077, HK
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Oman Medical Beauty Manufacture Limited (Owner Number: 10094349)
Owner / Operator Contact Address
Room B, 17/F, Run Kee Commercial Building, 680-682 Shanghai Street, Mong Kok, Hong Kong, HK-NOTA 999077, HK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

3D digital nail printer machine:MJY001,MJY002,MJY003,MJY004,MJY005,MJY006 Diode Laser Hair Removal System OMG90,OMG126,OMG176,OMG184,OMG185,OMG186,OMG187,OMG188,LD015,OMG200, OMD35,OMG17,OMG36,OMG45,OMG47,OMG74,OMG80,OMG83,OMG109,OMG112,OMG113, Multi-functional Cryolipolysis Slimming System:OMG09,OMG26,OMF72,OME57,OM253,OMF72,OMF76,OME78,OMG105,OMC86,OM173, OMG202,OMG216,LD005,LD006,LD007,LD009,LD010,LD11,LD12,LD013,LD014,LD016,LD017, LD018,LD19,LD20,LD22,LD263,OMG37,LD24,LD25,LD26,LD27,LD28,LD29,LD30 OMG97,OMG122,OMG123,OMG124,OMG133,OMG194,OMG195,OMG196,OMG201,OMG220,BZY001,BZY002, RF Cavitation machine:AGF67,AMB97,OM63,OMG16,OMG16,OMG75,OMG85, BZY014,BZY015,BZY016,BZY017,BZY018,BZY019,BZY020,BZY021,BZY022,BZY023,BZY024,BZY025, BZY003,BZY004,BZY004,BZY005,BZY006,BZY007,BZY008,BZY009,BZY010,BZY011,BZY012,BZY013, BZY026,BZY027,BZY028,BZY029,BZY030,BZY031,BZY032,BZY033,BZY034 WL0014,WL0015,WL0016,WL0017,WL0018,WL0019 Velashape machine:WL005,WL0011,WL006,WL001,WL009,WL0012,WL0013, WZ0010.WZ0011,WZ0012,WZ0013,WZ0014,WZ0015,WZ0016,WZ0017,WZ0018,WZ19,WZ0020, WZ0021,WZ0022,WZ0023,WZ0026,WZ0025,WZ0026,WZ0027,WZ00028,WZ0029,WZ0030 Rf Microneedling Machine:OMH61,MT01,MT02,MT04,MT06,MT09,WZ004,MT03,OM214,OMG71,OMD83,OMG53, OMG141,OMG168,OMG207,WZ001,WZ002,WZ003,WZ005,WZ009,WZ006,WZ007,WZ008,WZ009, CO2 Laser slimming machine :OMG103, OMG115, OMG152, OMG169, JGJF001, JGJF002, JGJF003, JGJF004, JGJF005, JGJF006, JGJF007, JGJF008, JGJF009, JGJF0010, JGJF0011, JGJF0012, JGJF0013, JGJF0014, EMS face:CL001,CL001,CL003,CL004,CL005,CL006,CL007,CL008,CL009 JGJF0015, JGJF0016, JGJF0017, JGJF0018, JXY-JGJF001, XOM-JGJF001, XOM-JGJF002 OMG157,OMG192,OMG208,OMG212,OMG221,JXY-CJB001,XOM-LLY001,XOM-LLY002,YTL-CJB001 Shockwave therapy:AG213,AGF66,AME25,MT07,MT08,OM213,OMG87,OMG110,OMG111,OMG119, Diode Laser Hair Removal System:AG108, AME50, OM101, OMG32, OMG121, OMG132, OMG134, OMG137, OMG138, OMG178, OMG179, XOM-TMY002, XOM-TMY003 TMY040, TMY041, TMY042, TMY043, TMY044, JXY-TMY001, JXY-TMY002, JXY-TMY003, JXY-TMY004, JXY-TMY005, XOM-TMY001, TMY025, TMY026, TMY027, TMY028, TMY029, TMY030, TMY031, TMY032, TMY033, TMY034, TMY035, TMY036, TMY037, TMY038, TMY039, OMG181, OMG214, OMG218, TMY001, TMY002, TMY003, TMY004, TMY005, TMY006, TMY007, TMY008, TMY009, TMY010, TMY011, TMY012, TMY013, TMY014, TMY015, TMY016, TMY017, TMY018, TMY019, TMY020, TMY021, TMY022, TMY023, TMY024, Multi-functional 980 1470 Diode Laser Machine:LLY006, LLY007, LLY008 ,LLY0030,LLY0043, OM213 Colon hydrotherapy machine:YL001,YL002,YL003,YL004,YL005,YL006,YL007 Spa Beauty bed:MRC001,MRC002,MRC003,MRC004,MRC005,MRC006,MRC007,MRC008,MRC009 Hair Regrowth Machine:OMG118,OMG153,SFY001,SFY002,SFY003,SFY004,YTL-SFY005 Skin analyzer machine:KSH75,PFFX001,PFFX002,PFFX005,OM26,PFFX005,PFFX008,PFFX0011,PFFX0014 ELECTRONIC MUSCLE STIMULATOR Fractional CO2 Laser System Machine:AGF80, AME85, DZ001, DZ008, DZ009, DZ010, DZ012, DZ013, DZ014, DZ015, DZ016, DZ018, DZ019, DZ010, DZ021, DZ027, DZ030, DZ031, DZ032, DZ033, DZ034, DZ035, DZ036, DZ037 Body analyzer machine:C27,OM33,PFFX006,PFFX009,PFFX016 Omg68,Omg69,Omg89,Omg99,Omg120,Omg139,Omg140,Omg142,Omg158,Omg170, Facial Spa Oxygen Hydro Facial Beauty System:AG51,AG154,AGF04,AGF54,AGF55,AGF68,AMB53,Keysun160,ksh75,Omd85,Omg25,Omg57, YTL-SYY001,YTL-SYY002,YTL-SYY003 Omg197,Omg203,Omg205,Omg209,Omg213,Omg215,JXY-SYY001,JXY-SYY002, Hyperbaric Oxygen Chamber:OMG-TKC009,OMG-TCK011,JXY-GYYC001 Spa capsule:AGF74,AM226,KS43,OMG125 JXY-SYY003,JXY-SYY004,JXY-SYY005,JXY-SYY006,JXY-SYY007, XOM-SYY001, Hyperbaric oxygen chamber:GY001,GY002,GY003,GY004,GY005,GY006 Muscle Stimulation EMS Sculpting Machines:AME83,KSH64,OMG127,OMG128,OMG129,OMG174,CLS0017,CLS0018,CLS0019,CLS0021, CLS30,CLS31,CLS32,CLS0033,CLS0037,CLS0038 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,

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2025-11-24
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-11-24
OUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite General, Plastic Surgery Class 2 878.4790 2025-11-24
IRQ Unit, Heating, Powered Physical Medicine Class 1 890.5950 2025-11-24
IRO Vibrator, Therapeutic Physical Medicine Class 1 890.5975 2025-11-24
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2025-11-24
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-11-24
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2025-11-24
PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers General, Plastic Surgery Class 2 878.4685 2025-11-24
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-11-24
KPL Colonic Irrigation System Gastroenterology, Urology Class 2 876.5220 2025-11-24
FNJ Bed, Manual General Hospital Class 1 880.5120 2025-11-24
OAP Laser, Comb, Hair Physical Medicine Class 2 890.5500 2025-11-24
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2025-11-24
DLI Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase Clinical Toxicology Class 1 862.3240 2025-11-24
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2025-11-24
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2025-11-24
ECB Unit, Syringe, Air And/Or Water Dental Class 1 872.4565 2025-11-24

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

Oman Medical Beauty 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
K781173 Instrumentation Laboratory CO COMPUTER INTERFACE IL 814 1978-09-14
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042228064. Last updated year: 2026. Please use registration number 3042228064 when referencing this establishment in official correspondence.
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