Home GUDID 17290112452013
Silk'n
Primary DI 17290112452013
Brand Silk'n
Company HOME SKINOVATIONS LTD
Model BellaVisage Hybrid
Catalog number 7290112452016
Device description The BellaVisage Hybrid is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n BellaVisage Hybrid is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains.
Published 2021-08-08
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 Code Name OHS Light Based Over The Counter Wrinkle Reduction PAY Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OHS Light Based Over The Counter Wrinkle Reduction General, Plastic Surgery 2 PAY Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290112452016 Direct Marking GS1 0 17290112452013 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290112452016 07290112452016 7290112452016 17290112452013 17290112452013
GMDN Terms# Term, Definition table Term Definition Radio-frequency skin surface treatment system An assembly of devices designed to apply radio-frequency (RF) energy to heat the skin surface for ablation, coagulation, and tightening of the skin?s outer later (stratum corneum) for aesthetic skin resurfacing. It primarily consists of a mains electricity (AC-powered) control unit to produce and regulate the RF energy, and a connected bipolar RF applicator (handpiece) to deliver the RF energy to the skin surface; the applicator may include vacuum to facilitate its coupling with the skin.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 30 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 35 Degrees Celsius Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature -40 Degrees Celsius 70 Degrees Celsius
Regulatory Flags# DUNS number 514891048 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00622356646390 Shark CryoGlow SharkNinja Operating LLC OHS 2026-06-02 00622356663076 Shark CryoGlow SharkNinja Operating LLC OHS 2026-06-02 00622356669351 Shark CryoGlow SharkNinja Operating LLC OHS 2026-06-02 00622356669597 Shark CryoGlow SharkNinja Operating LLC OHS 2026-06-02 00622356706926 Shark CryoGlow SharkNinja Operating LLC OHS 2026-06-02 10622356642801 Shark CryoGlow SharkNinja Operating LLC OHS 2026-06-02 06974020961372 Brookstone Guangdong Newdermo Biotech Co.,Ltd. OHS 2026-05-28 06980088700006 Kakusan SZ KKS Silicone&Electronic Co.,Ltd OHS 2026-05-13 06980088700013 Kakusan SZ KKS Silicone&Electronic Co.,Ltd OHS 2026-05-13 06980088700020 Kakusan SZ KKS Silicone&Electronic Co.,Ltd OHS 2026-05-13 18712856075024 Silk'n Silkn Beauty Ltd. OHS 2026-05-07 00850001456784 MODEL S+ BY SPIRULUX Omm Imports Inc. OHS 2026-05-03 00850001456791 PRO MED BY JOUVALLE Omm Imports Inc. OHS 2026-05-02 08056389701115 YOUNG AGAIN ESPANSIONE MARKETING SPA OHS 2026-04-30 B347202366010 Dr Dennis Gross Skincare LED TECHNOLOGIES INC OHS 2026-04-23 B347202366020 Dr Dennis Gross Skincare LED TECHNOLOGIES INC OHS 2026-04-23 B347202366030 Dr Dennis Gross Skincare LED TECHNOLOGIES INC OHS 2026-04-23 06977168990129 Nuon Shenzhen Nuon Medical Equipment Co., Ltd. OHS 2026-04-21 06977168990143 Nuon Shenzhen Nuon Medical Equipment Co., Ltd. OHS 2026-04-21 06977168990150 Nuon Shenzhen Nuon Medical Equipment Co., Ltd. OHS 2026-04-21 06977168990167 Nuon Shenzhen Nuon Medical Equipment Co., Ltd. OHS 2026-04-21 06977168990174 Nuon Shenzhen Nuon Medical Equipment Co., Ltd. OHS 2026-04-21 06977168990181 Nuon Shenzhen Nuon Medical Equipment Co., Ltd. OHS 2026-04-21 06977168990273 Nuon Shenzhen Nuon Medical Equipment Co., Ltd. OHS 2026-04-21 06974958310549 ideatherapy Shenzhen Idea Light Limited OHS 2026-04-17 06974958310556 LIFEPRO FITNESS Shenzhen Idea Light Limited OHS 2026-04-17 06974958310563 LIFEPRO FITNESS Shenzhen Idea Light Limited OHS 2026-04-17 06978368600221 Dreame Shenzhen Rainbow Technology Co.,Ltd OHS 2026-04-07 06978368600238 Dreame Shenzhen Rainbow Technology Co.,Ltd OHS 2026-04-07 06978368600245 Dreame Shenzhen Rainbow Technology Co.,Ltd OHS 2026-04-07