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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K172639
Device Name PALLAS 308/311 Solid-State UV Laser System
Applicant
Laseroptek Co., Ltd.
#203 & #204 Hyundai 1 Valley 31
Galmachiro,Jungwon-Gu
Gyeonggido,  KR
Applicant Contact Hong Chu
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/01/2017
Decision Date 11/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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