FDA Registration
Active
🇺🇸 United States
HydraFacial LLC
Reg #: 3016453096
·
FEI: 3016453096
·
Expires 2026
Products
4
Proprietary Names
60
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- HydraFacial LLC
- Registration Number
- 3016453096
- FEI Number
- 3016453096
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3600 E. Burnett St.
- City
- Long Beach
- State
- CA
- ZIP
- 90815
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231073
Owner / Operator
- Firm Name
- HYDRAFACIAL LLC
- Operator Number
- 9032809
- Address
- 3600 E. Burnett St, --
- City
- Long Beach
- State
- CA
- Postal Code
- 90815
- Country
- US
- Correspondent
- Vineetha Murickan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Microneedle Device | QAI | Class 2 | General, Plastic Surgery | No | 2024-08-13 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2001-08-07 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2008-01-07 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2017-04-28 |
Proprietary Names
SkinStylus Sterilock® Cartridge 12pin (10445)
SkinStylus SteriLock® MicroSystem (4501)
SkinStylus Sterilock® Cartridge HiLo (SL38679)
SkinStylus Sterilock® Cartridge 36pin (10446)
7000078-WHT-Dior HydraFacial Syndeo - White (120V)
70185 Cleaning Caps
70144 Lymphatic Drainage Therapy Kit
72293 Handpiece Body Assembly
70142 Crystal-Free Kit HydraFacial
70143-03-01 HydraFacial MD Elite (120V)
70415 HydraFacial MD Allegro (120V)
7000079-WHT HydraFacial Syndeo - White (240V)
71166 Small Glass Cup
7000136 HydraFacial Syndeo Accessory Kit 120V
7000131 HydraFacial Syndeo Lymphatic Kit
7000192 HydraFacial Syndeo Dior Handpiece Tubing
74111-15 HydroPeel Tip, Large Clear
70143-03-01-FRC HydraFacial MD Elite (120V) REFURB
71167 Large Glass Cup
7000078-BLK-FRC HydraFacial Syndeo - Black (120V) REFURB
70218 HydroPeel Tip, Body Blue
7000200 HydraFacial Syndeo Dior White Handpiece Kit
70416 HydraFacial Allegro (120V)
7000078-WHT HydrFacial Syndeo - White (120V)
70154-03-01 FRC HydraFacial Elite (240V) REFURB
7000079-WHT-DIOR HydraFacial Syndeo - White (240V)
7000201 HydraFacial Syndeo Dior Handpiece
7000079-BLK-FRC HydraFacial Syndeo - Black (240V) REFURB
70290-03-01 HydraFacial MD Elite (240V)
7000126 HydraFacial Syndeo Black Handpiece Kit
70413 HydraFacial MD Allegro (240V)
74114-15 HydroPeel Tip, Small Teal
70143-03-01-TUFRC HydraFacial MD Elite (120V) REFURB
70482 HydraFacial Handpiece
74275-15 HydroPeel Tip, Orange Aggression
74462-15 HydroPeel Tip, Purple Aggression
70135-03-01-FRC HydraFacial Elite (120V) REFURB
70290-03-01-ITL HydraFacial Elite (240V)
7000078-BLK HydraFacial Syndeo - Black (120V)
71107 Single Cup Tubing Replacement
74112-15 HydroPeel Tip, Large Blue
7000078-BLK-INT HydraFacial Syndeo-Black (120V)
7000137 HydraFacial Syndeo Accessory Kit 240V
7200114 Rollerball Tip
7000079-BLK HydraFacial Syndeo - Black (240V)
70303-02 Wet Diamond Replacement Pad 100 Grit
71168 Split Cup Tubing Replacement
70290-03-01-FRC HydraFacial MD Elite (240V) REFURB
70303-01 Wet Diamond Replacement Pad 120 Grit
7200227 Hydrafacial Purify Tip
7400000-15 HydraFacial Keravive Tip
70154-03-01 HydraFacial Elite (240V)
70301 Wet Diamond Kit
7200226 Hydrafacial Nourish Tip
70318 HydraFacial Handpiece
7000191 HydraFacial Syndeo Dior Black Handpiece Kit
70290-03-01-TUFRC HydraFacial MD Elite (240V) REFURB
7200225 Hydrafacial Lip Tip
Del Sol Blue Light Therapy System
Del Sol Red Light Therapy System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device