Data / Medical devices / United States / HydraFacial LLC

HydraFacial LLC: FDA-registered device maker in Long Beach, CA, United States, 7 510(k) clearances

Name: HydraFacial LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

HydraFacial LLC is registered with the FDA (registration 3016453096) in Long Beach, CA, United States. It lists 9 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 8, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016453096
Address: 3600 E. Burnett St., Long Beach, CA, United States, 90815
Owner or operator: HYDRAFACIAL LLC (9032809)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: August 7, 2001
Registered through: 2026
Brand names listed: 7000078-BLK HydraFacial Syndeo - Black (120V), 7000078-BLK-FRC HydraFacial Syndeo - Black (120V) REFURB, 7000078-BLK-INT HydraFacial Syndeo-Black (120V), 7000078-WHT HydrFacial Syndeo - White (120V), 7000078-WHT-Dior HydraFacial Syndeo - White (120V), 7000079-BLK HydraFacial Syndeo - Black (240V), 7000079-BLK-FRC HydraFacial Syndeo - Black (240V) REFURB, 7000079-WHT HydraFacial Syndeo - White (240V) and more

Devices it lists

Device	Product code	Class	Role	Source
Brush, Dermabrasion, Powered	GFE	1	Manufacturer	accessdata.fda.gov
Contact Cooling For Skin Lesion Pain Relief	QPZ	2	Repackager or relabeler	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Manufacturer	accessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced Heat	PBX	2	Repackager or relabeler	accessdata.fda.gov
Pad, Heating, Powered	IRT	2	Repackager or relabeler	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Powered Microneedle Device	QAI	2	Specification developer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Repackager or relabeler	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
June 8, 2026	K253542	Apollo Quattro (APQ-10M)	IPF	Substantially Equivalent	Weero Co., Ltd.	accessdata.fda.gov
March 13, 2026	K253261	Apollo Quattro (APQ-10M)	PBX	Substantially Equivalent	Weero Co., Ltd.	accessdata.fda.gov
February 19, 2026	K253002	SkinStylus SteriLock MicroSystem (MP1209SL)	QAI	Substantially Equivalent	Esthetic Medical, Inc.	accessdata.fda.gov
July 28, 2023	K231073	SkinStylus SteriLock® MicroSystem, Model Number MP1209SL	QAI	Substantially Equivalent	Esthetic Medical, Inc.	accessdata.fda.gov
April 10, 2020	K200044	SkinStylus SteriLock MicroSystem	QAI	Substantially Equivalent	Esthetic Education, LLC	accessdata.fda.gov
May 23, 2008	K072399	DEL SOL RED LIGHT THERAPY SYSTEM	ILY	Substantially Equivalent	Edge Systems, Inc.	accessdata.fda.gov
July 20, 2006	K061470	DEL SOL BLUE LIGHT THERAPY SYSTEM	GEX	Substantially Equivalent	Edge Systems Corporation	accessdata.fda.gov

Compare with other makers

Updated June 8, 2026. 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.