Powered Laser Surgical Instrument

SNJ Co., Ltd.

The following data is part of a premarket notification filed by Snj Co., Ltd. with the FDA for Finebeam.

Pre-market Notification Details

Device IDK202288
510k NumberK202288
Device Name:Finebeam
ClassificationPowered Laser Surgical Instrument
Applicant SNJ Co., Ltd. No. 604, Ace-Techno Tower 2, Digital-ro 31-gil 19, Guro-gu Seoul,  KR 08381
ContactHyang-kee Lee
CorrespondentJongrak Kim 2202 Gongwon-ro, Guro-gu Seoul,  KR 08295
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-12
Decision Date2021-11-19

© 2021
This site is not affiliated with or endorsed by the FDA.