FDA.reportPublic FDA data

Nu Skin RenuSpa iO Package

Primary DI
00850021097561
Brand
Nu Skin RenuSpa iO Package
Company
NSE PRODUCTS, INC.
Model
01002910
Published
2023-11-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
GYBMedia, electroconductive
NFOStimulator, transcutaneous electrical, aesthetic purposes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYBMedia, ElectroconductiveNeurology2
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022006000
K232001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022006000CONDUCTIVE GELThe Dezac Group2002-09-13GYB
K232001000Nu Skin RenuSpa iONse Products, Inc.2023-11-21NFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850021097561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850021097561008500210975618500210975610850021097561

GMDN Terms#

Term, Definition table
TermDefinition
Skin topical coupling gelA medium designed to be applied to a patient's unbroken skin surface (excludes the eye surface) to provide a coupling between an analytical or therapeutic device (e.g., ultrasound transducer, optical glucose monitoring system, transcutaneous electrical stimulator) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light) that pass through the skin during an examination or treatment. It is in the form of a fluid-like gel that may also assist in moving the parent device smoothly over the skin. It may be used by a healthcare professional in a clinical setting and layperson in the home. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
803486393
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860196000310Nu Skin Conductive Gel10039132016-09-28
00860196000327Nu Skin Facial Spa Package10013522016-09-28
00850021097554Nu Skin RenuSpa iOBS2RM2023-11-27
00850021097578AP 24® Smile Pop Toothbrush0016492023-08-11
00860196000303Nu Skin Facial Spa900255092016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851367006224ZIIP BeautyZIIP, INC.NFO2026-04-22
00851530007621AvazziaAVAZZIA INCNFO2026-04-21
00851530007638AvazziaAVAZZIA INCNFO2026-04-21
06977168990013NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
06977168990129NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
06977168990150NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
06977168990273NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
09342451003416Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
09342451003423Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
09342451003430Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
09342451003447Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
00850021950088Medi Lift YA-MAN LTD.NFO2026-02-19
00197998355363Solventum™Solventum US LLCGYB2026-02-15
00197998355400Solventum™Solventum US LLCGYB2026-02-15
00197998355370Solventum™Solventum US LLCGYB2026-02-15
00197998355417Solventum™Solventum US LLCGYB2026-02-15
00810075943276NuFACENufaceNFO2026-01-27
00810075944570NuFACENufaceNFO2026-01-27
00850021950071Medi Lift YA-MAN LTD.NFO2026-01-14
06979082450000FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
06979082450017FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
06979082450024FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
06973602730795FyneLookTOP-RANK HEALTH CARE CO., LTD.GYB2025-10-23
00851367006217ZIIP BeautyZIIP, INC.NFO2025-09-30
05391540830871Préime DermaFacial EMA AESTHETICS LIMITEDNFO2025-09-15
00851367006163ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006170ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006187ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006194ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006200ZIIP BeautyZIIP, INC.NFO2025-08-07