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FDA 510(k)

Picosecond Laser System (Model PS10-A and PS10-B)

K-Number: K220268 · 2022-08-23

ApplicantBeijing Adss Development Co., Ltd.
Decision Date2022-08-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Picosecond Laser System (Model PS10-A and PS10-B) is a medical device manufactured by Beijing Adss Development Co., Ltd.. It received FDA 510(k) clearance on 2022-08-23 under approval number K220268. 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 Picosecond Laser System (Model PS10-A and PS10-B)?

Picosecond Laser System (Model PS10-A and PS10-B) is a medical device that received FDA 510(k) clearance on 2022-08-23. It is manufactured by Beijing Adss Development Co., Ltd.. The 510(k) number is K220268.

When was Picosecond Laser System (Model PS10-A and PS10-B) approved by the FDA?

Picosecond Laser System (Model PS10-A and PS10-B) received FDA 510(k) clearance on 2022-08-23, under approval number K220268.

What company makes Picosecond Laser System (Model PS10-A and PS10-B)?

Picosecond Laser System (Model PS10-A and PS10-B) is manufactured by Beijing Adss Development Co., Ltd..

What is the FDA product code for Picosecond Laser System (Model PS10-A and PS10-B)?

The FDA product code for Picosecond Laser System (Model PS10-A and PS10-B) is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

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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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