HydraFacial LLC

FDA Device Registration & Listing · Long Beach, CA, US · Registration 3016453096

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
3016453096
FEI Number
3016453096
Entity Name
HydraFacial LLC
City/State/Country
Long Beach, CA, US
Establishment Address
3600 E. Burnett St., Long Beach, CA 90815, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
HYDRAFACIAL LLC (Owner Number: 9032809)
Owner / Operator Contact Address
3600 E. Burnett St, --, Long Beach, CA 90815, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K072399
PMA Number
N/A

All Registered 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 SkinStylus Sterilock® Cartridge 12pin (10445) SkinStylus SteriLock® MicroSystem (4501) SkinStylus Sterilock® Cartridge HiLo (SL38679) SkinStylus Sterilock® Cartridge 36pin (10446) SkinStylus Sterilock® Cartridge HiLo (SL38679) SkinStylus SteriLock® MicroSystem (4501) SkinStylus Sterilock® Cartridge 12pin (10445) SkinStylus Sterilock® Cartridge 36pin (10446) Del Sol Blue Light Therapy System Del Sol Red Light Therapy System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QAI Powered Microneedle Device General, Plastic Surgery Class 2 878.4430 2024-08-13
GFE Brush, Dermabrasion, Powered General, Plastic Surgery Class 1 878.4820 2001-08-07
QAI Powered Microneedle Device General, Plastic Surgery Class 2 878.4430 2024-08-13
QAI Powered Microneedle Device General, Plastic Surgery Class 2 878.4430 2026-03-27
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-01-07
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2017-04-28

Official Correspondent

Vineetha Murickan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HYDRAFACIAL LLC
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
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
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

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, 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 3016453096. Last updated year: 2026. Please use registration number 3016453096 when referencing this establishment in official correspondence.
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