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FDA 510(k)

PicoLO Premium

K-Number: K212573 · 2021-12-08

ApplicantLaseroptek Co., Ltd.
Decision Date2021-12-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PicoLO Premium 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 2021-12-08 under 510(k) number K212573. 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 PicoLO Premium?

PicoLO Premium is a medical device that received FDA 510(k) clearance on 2021-12-08. The listed applicant is Laseroptek Co., Ltd.. The 510(k) number is K212573.

When did PicoLO Premium receive FDA 510(k) clearance?

PicoLO Premium received FDA 510(k) clearance on 2021-12-08, under 510(k) number K212573.

Who is the listed applicant for PicoLO Premium?

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 PicoLO Premium?

The FDA product code for PicoLO Premium is GEX. This falls under the Gastroenterology category.

Other records listing Laseroptek Co., Ltd. as applicant

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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