Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013917867

FEI Number

3013917867

Entity Name

PREFERRED DEPOT

City/State/Country

Irvine, CA, US

Establishment Address

39 Parker, Irvine, CA 92618, US

Establishment Type(s)

Remanufacture Medical Device,Repack or Relabel Medical Device

Owner / Operator

Preferred Depot (Owner Number: 10060025)

Owner / Operator Contact Address

39 parker, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191421

PMA Number

N/A

All Registered Proprietary Names

PathKeeper System FSR Fractional Skin Resurfacing Applicator BRH Medical Ltd. Sofwave Sofwave I-Tech Industries Sofwave Inc. Newa Over the Counter EndyGel Newa Skin Therapy System Contour I-Tech Industries SRL Endymed Sofwave Inc.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-03-09
OUH	Skin Resurfacing Rf Applicator	General, Plastic Surgery	Class 2	878.4400	2019-03-21
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2022-10-25
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2022-10-25
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5300	2022-10-25
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2022-10-25
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-09-03
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-07-14
OHV	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption	General, Plastic Surgery	Class 2	878.4590	2025-07-14
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2024-06-25
OHV	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption	General, Plastic Surgery	Class 2	878.4590	2022-07-15
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4420	2019-03-21
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2019-03-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-03-21
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2019-03-21
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2024-06-25
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2024-06-25
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-11-25
OHV	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption	General, Plastic Surgery	Class 2	878.4590	2019-11-25

Official Correspondent

Isaac Elkah

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Preferred Depot

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
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03
K820884	Nitron Electronics	ELECTRICAL MUSCLE STIMULATOR	1982-04-29
K201958	Therasigma, LLC	ETD Family of Electrotherapy Devices	2020-08-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-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 3013917867. Last updated year: 2026. Please use registration number 3013917867 when referencing this establishment in official correspondence.