EUNSUNG GLOBAL CORP.

Address:120, Gieopdosi-ro, Jijeong-myeon,,Wonju-si Gangwon,KR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Brush, Dermabrasion, Powered (GFE) (4) Massager, Therapeutic, Electric (ISA) (1)

Premarket Exempt

Yes

Clear

HYDRA BEAUTY - 08800060501644 Catalog Number :

Device Description : Hydra Beauty is equipped with two functions. First, the ‘Aqua peel cleansing’ wh Hydra Beauty is equipped with two functions. First, the ‘Aqua peel cleansing’ which is using chemical peel to help clear skin pores and eliminating hazardous wastes. Secondly, Low frequency radiofrequency (EP) stimulates muscle relaxation and hormone secretion for pain relief.

Device Class :

Duns Number: 689372738

Premarket Exempt : Yes

Product Code : GFE

Prescription Use : No

Device Count : 1

HYDRA TOUCH H2 - 08800060501651 Catalog Number :

Device Description : Hydra touch H2 is equipped with two functions. First, the ‘Aqua cleansing’ which Hydra touch H2 is equipped with two functions. First, the ‘Aqua cleansing’ which is using hydrogen water and chemical peel to help clear skin pores and eliminating hazardous wastes. Secondly, Medium and low frequency radiofrequency (Y-type, Multi-type, and Electrozyme) stimulate muscle relaxation and hormone secretion for pain relief.

Device Class :

Duns Number: 689372738

Premarket Exempt : Yes

Product Code : GFE

Prescription Use : No

Device Count : 1

HYPER JET - 08800060501668 Catalog Number :

Device Description : While vibrating at a high speed, the microtips of this device apply physical sti While vibrating at a high speed, the microtips of this device apply physical stimulation to the facial skin to facilitate active ingredients to penetrate in the skin.

Device Class : 1

Duns Number: 689372738

Premarket Exempt : Yes

Product Code : GFE

Prescription Use : No

Device Count : 1

JET CLEAR - 08800060501675 Catalog Number :

Device Description : The jet gun sprays water and pressurized air to perform fine exfoliation, removi The jet gun sprays water and pressurized air to perform fine exfoliation, removing dead skin cell, while the spray handpiece sprays fine particles of solution, helping the solution to penetrate deep into the skin.

Device Class :

Duns Number: 689372738

Premarket Exempt : Yes

Product Code : GFE

Prescription Use : No

Device Count : 1

V-ROLL - 08800060501682 Catalog Number :

Device Description : 1KHz Low and blood frequency electric current circulation. energy able to massag 1KHz Low and blood frequency electric current circulation. energy able to massage the muscles with systaltic system and promote nervous With the double ball on Vroll , gives lowsedation frequency energy on the skin, eventually make the skin more elastic POINT 1 and have dramatic lifting effects.

Device Class : 1

Duns Number: 689372738

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

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