SmoothCool HR System

Powered Laser Surgical Instrument

Jeisys Medical Inc

The following data is part of a premarket notification filed by Jeisys Medical Inc with the FDA for Smoothcool Hr System.

Pre-market Notification Details

Device IDK213484
510k NumberK213484
Device Name:SmoothCool HR System
ClassificationPowered Laser Surgical Instrument
Applicant Jeisys Medical Inc 307, 308, 401, Daeryung Techno Town 8th, 96, Gamasan-ro, Geumcheon-Gu Seoul,  KR 08501
ContactSang Hoon Hwang
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine,  CA  92612
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-29
Decision Date2022-04-20

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