FDA 510(k)

PicoWay Laser System

K-Number: K220853 · 2022-10-13

Decision Date2022-10-13

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PicoWay Laser System is a medical device manufactured by Candela Corporation. It received FDA 510(k) clearance on 2022-10-13 under approval number K220853. 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 PicoWay Laser System?

PicoWay Laser System is a medical device that received FDA 510(k) clearance on 2022-10-13. It is manufactured by Candela Corporation. The 510(k) number is K220853.

When was PicoWay Laser System approved by the FDA?

PicoWay Laser System received FDA 510(k) clearance on 2022-10-13, under approval number K220853.

What company makes PicoWay Laser System?

PicoWay Laser System is manufactured by Candela Corporation.

What is the FDA product code for PicoWay Laser System?

The FDA product code for PicoWay Laser System is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

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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.