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FDA 510(k)

HELIOS 785 Pico (1754V2)

K-Number: K243780 · 2025-02-07

ApplicantLaseroptek Co., Ltd.
Decision Date2025-02-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HELIOS 785 Pico (1754V2) 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 2025-02-07 under 510(k) number K243780. 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 785 Pico (1754V2)?

HELIOS 785 Pico (1754V2) is a medical device that received FDA 510(k) clearance on 2025-02-07. The listed applicant is Laseroptek Co., Ltd.. The 510(k) number is K243780.

When did HELIOS 785 Pico (1754V2) receive FDA 510(k) clearance?

HELIOS 785 Pico (1754V2) received FDA 510(k) clearance on 2025-02-07, under 510(k) number K243780.

Who is the listed applicant for HELIOS 785 Pico (1754V2)?

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 785 Pico (1754V2)?

The FDA product code for HELIOS 785 Pico (1754V2) 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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