Address:116~122ho, Jungang Induspia 3, 27, Sagimakgol-ro 105beon-gil,Seongnam Gyeonggi,KR
Device Description : This Head-worn light is used for medical examination by fixing it on the head an This Head-worn light is used for medical examination by fixing it on the head and illuminating with condensed light to the injured part. This unit doesn't intend to contact directly to the patient's body and can be used for all medical field except ophthalmology.
Device Class :
Duns Number: 689908411
Premarket Exempt : Yes
Prescription Use : No
Device Description : This Head-worn light is used for medical examination by fixing it on the head an This Head-worn light is used for medical examination by fixing it on the head and illuminating with condensed light to the injured part. This unit doesn't intend to contact directly to the patient's body and can be used for all medical field except ophthalmology.
Device Class : 1
Duns Number: 689908411
Premarket Exempt : Yes
Prescription Use : No
Device Description : This device is indicated for use to treatment of infants diagnosed with hyperbil This device is indicated for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home.The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.
Device Class : 2
Duns Number: 689908411
Premarket Exempt : No
Prescription Use : Yes
Device Description : This device is indicated for use to treatment of infants diagnosed with hyperbil This device is indicated for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home.The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.
Device Class : 2
Duns Number: 689908411
Premarket Exempt : No
Prescription Use : Yes