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FDA 510(k)

PicoWay Laser System

K-Number: K191685 · 2019-09-16

ApplicantCandela Corporation
Decision Date2019-09-16
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 2019-09-16 under approval number K191685. 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 2019-09-16. It is manufactured by Candela Corporation. The 510(k) number is K191685.

When was PicoWay Laser System approved by the FDA?

PicoWay Laser System received FDA 510(k) clearance on 2019-09-16, under approval number K191685.

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

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

Other Devices by Candela Corporation

K201111GentleMax Pro Plus K212492Frax 1940 for Nordlys and Frax Pro K211217Profound Matrix K220853PicoWay Laser System K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) K240070Profound Matrix

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Related Devices (Code: GEX)

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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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