HULASER, Inc.

Address:1110, DAERUNG TECHNOTOWN 17, 25, GASAN DIGITAL 1-RO,GEUMCHEON-GU 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

Powered Laser Surgical Instrument (GEX) (1)

Premarket Exempt

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K2 MOBILE - 08800079000008 Catalog Number :

Device Description : K2 MOBILE LASER IS INTENDED FOR USE BY DENTISTS FOR EXCISION, INCISION, VAPORIZA K2 MOBILE LASER IS INTENDED FOR USE BY DENTISTS FOR EXCISION, INCISION, VAPORIZATION, ABLATION AND COAGULATION OFORAL SOFT TISSUE PROCEDURES, INCLUDING TOOTH WHITENING AND THE TEMPORARY RELIEF OF PAIN.

Device Class : 2

Duns Number: 688409662

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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