Daeju Medi Tech Engineering

Address:#501-504, HausD Sejong Tower, 26, Seongsu-il-ro 10-gil,Seoul,KR

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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

Light Based Over-The-Counter Hair Removal (OHT) (1)

Premarket Exempt

Clear

AROMA GRAND - 08800017500126 Catalog Number :

Device Description : The subject device, AROMA GRAND is a surgical device, which is intended for hair The subject device, AROMA GRAND is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser hand-piece.

Device Class : 2

Duns Number: 694492044

Premarket Exempt : No

Product Code : OHT

Prescription Use : Yes

Device Count : 1

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