PicoLO Nd: YAG Picosecond Laser System

Powered Laser Surgical Instrument

Laseroptek Co., Ltd.

The following data is part of a premarket notification filed by Laseroptek Co., Ltd. with the FDA for Picolo Nd: Yag Picosecond Laser System.

Pre-market Notification Details

Device IDK203491
510k NumberK203491
Device Name:PicoLO Nd: YAG Picosecond Laser System
ClassificationPowered Laser Surgical Instrument
Applicant Laseroptek Co., Ltd. #203 & #204 Hyundai I Valley, 31, Galmachi-ro 244 Beon-gil, Seongnam-si,  KR 13212
ContactHong Chu
CorrespondentDo Hyun Kim
BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul,  KR 06210
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-27
Decision Date2021-04-07


Device IdentifiersubmissionNumberSupplement
08800035501242 K203491 000
08800035501235 K203491 000
08800035501228 K203491 000
08800035501211 K203491 000
08800035501204 K203491 000
08800035501198 K203491 000
08800035501181 K203491 000
08800035501259 K203491 000

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