HELIOS IV 785

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 Helios Iv 785.

Pre-market Notification Details

Device IDK212663
510k NumberK212663
Device Name:HELIOS IV 785
ClassificationPowered Laser Surgical Instrument
Applicant Laseroptek Co., Ltd. #203 & #204 Hyundai I Valley, 31, Galmachi-ro 244 Beon-gil, Jungwon-gu 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-23
Decision Date2022-06-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800035501532 K212663 000
08800035501457 K212663 000
08800035501464 K212663 000
08800035501471 K212663 000
08800035501488 K212663 000
08800035501495 K212663 000
08800035501501 K212663 000
08800035501518 K212663 000
08800035501525 K212663 000
08800035501440 K212663 000

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