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FDA 510(k)

HELIOS IV 785

K-Number: K212663 · 2022-06-09

ApplicantLaseroptek Co., Ltd.
Decision Date2022-06-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HELIOS IV 785 is the device name listed in this FDA 510(k) record. The listed applicant is Laseroptek Co., Ltd.. It received FDA 510(k) clearance on 2022-06-09 under 510(k) number K212663. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELIOS IV 785?

HELIOS IV 785 is a medical device that received FDA 510(k) clearance on 2022-06-09. The listed applicant is Laseroptek Co., Ltd.. The 510(k) number is K212663.

When did HELIOS IV 785 receive FDA 510(k) clearance?

HELIOS IV 785 received FDA 510(k) clearance on 2022-06-09, under 510(k) number K212663.

Who is the listed applicant for HELIOS IV 785?

The FDA 510(k) record lists Laseroptek Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HELIOS IV 785?

The FDA product code for HELIOS IV 785 is GEX. This falls under the Gastroenterology category.

Other records listing Laseroptek Co., Ltd. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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