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FDA 510(k)

PicoWay Laser System

K-Number: K160607 · 2016-07-05

ApplicantSyneron Candela Corporation
Decision Date2016-07-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PicoWay Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Syneron Candela Corporation. It received FDA 510(k) clearance on 2016-07-05 under 510(k) number K160607. 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 2016-07-05. The listed applicant is Syneron Candela Corporation. The 510(k) number is K160607.

When did PicoWay Laser System receive FDA 510(k) clearance?

PicoWay Laser System received FDA 510(k) clearance on 2016-07-05, under 510(k) number K160607.

Who is the listed applicant for PicoWay Laser System?

The FDA 510(k) record lists Syneron Candela Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Syneron Candela Corporation as applicant

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.

K181523Syneron CO2RE SystemK180593Vbeam Prima Laser SystemK170597PicoWay Laser SystemK162454PicoWay Laser SystemK161043Profound SystemK153527PicoWay Laser System

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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.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

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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