FDA Registration
Active
🇭🇰 Hong Kong
OMAN MEDICAL BEAUTY MANUFACTURE LIMITED
Reg #: 3042228064
·
FEI: 3042228064
·
Expires 2026
Products
18
Proprietary Names
63
Establishment Types
2
Classifications
18
Registration Details
- Registration Name
- OMAN MEDICAL BEAUTY MANUFACTURE LIMITED
- Registration Number
- 3042228064
- FEI Number
- 3042228064
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room B, 17/F, Run Kee Commercial Building, 680-682 Shanghai Street, Mong Kok
- City
- Hong Kong
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K241860
Owner / Operator
- Firm Name
- Oman Medical Beauty Manufacture Limited
- Operator Number
- 10094349
- Address
- Room B, 17/F, Run Kee Commercial Building, 680-682 Shanghai Street, Mong Kok
- City
- Hong Kong
- State
- HK-NOTA
- Postal Code
- 999077
- Country
- HK
- Correspondent
- Shujuan Zhao
US Agent
- Business Name
- REPF America LLC
- Contact Name
- Wilson Li
- Address
- 6510 S Academy Blvd
- City
- Co Spgs
- State
- CO
- ZIP
- 80916
- Country
- US
- [email protected]
- Phone
- 719 2013315
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2025-11-24 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2025-11-24 |
| Powered Surgical Instrument For Improvement In The Appearance Of Cellulite | OUP | Class 2 | General, Plastic Surgery | No | 2025-11-24 |
| Unit, Heating, Powered | IRQ | Class 1 | Physical Medicine | No | 2025-11-24 |
| Vibrator, Therapeutic | IRO | Class 1 | Physical Medicine | No | 2025-11-24 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2025-11-24 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2025-11-24 |
| Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | PZL | Class 2 | General, Plastic Surgery | No | 2025-11-24 |
| Colonic Irrigation System | KPL | Class 2 | Gastroenterology, Urology | No | 2025-11-24 |
| Bed, Manual | FNJ | Class 1 | General Hospital | No | 2025-11-24 |
| Laser, Comb, Hair | OAP | Class 2 | Physical Medicine | No | 2025-11-24 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2025-11-24 |
| Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase | DLI | Class 1 | Clinical Toxicology | No | 2025-11-24 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2025-11-24 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2025-11-24 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2025-11-24 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2025-11-24 |
| Gas, Laser Generating | NXF | Class 1 | General, Plastic Surgery | No | 2025-11-24 |
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,
OMG193,HF006,HF0022,HF0017,HF0021,HF0026,HF007,HF008,HF0023,HF009,HF0010,HF0011,
HF0029,HF0031,HF0032,HF0033,HF0034,HF0035,HF0036,HF0037,HF0038,HF0039,
High Intensity Focused Ultrasound System:OM18,OM32 ,OMD04,OMF71,OME72,OM121,OM120,OM140,OMG77,OMG79,OMG108,
OMG114,OMG131,OMG165,OMG210,OMG166,OMG167,OMG177,OMG191,OMG206,HF0030,
HF0012,HF0013,HF0014,OMG135,HF0016,HF0018,HF0019,HF0020,HF0024,HF0025,AGF65,HF0028,
HF0040,HF0041,HF0042,HF0043
OMG207,OMG199,OMG198,OMG211,OMG217,OMG219,HF001,HF002,HF003,HF004,HF005,
PM009, PM011, PM012, PM015, PM016, PM017, PM022, PM023, PM024, PM025, PM026, PM028, PM029, PM033, PM034, PM035,
Picosecond Laser Machine:OMG30, OMG172, PM001, PM002, PM003, PM004, PM005, PM006, PM007, PM008,
PM036, PM037, PM038, JXY-PM001, JXY-PM0012, XOM-PM001, XOM-PM002,
Plasma beauty machine:OMG-LZB003,OMG-LZB004,OMG-LZB005,OMG-LZB008,OMG-LZB009
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)