PURE Laser
K-Number: K222369 · 2022-10-07
ApplicantEndymed Medical, Ltd.
Decision Date2022-10-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PURE Laser is a medical device manufactured by Endymed Medical, Ltd.. It received FDA 510(k) clearance on 2022-10-07 under approval number K222369. 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 PURE Laser?
PURE Laser is a medical device that received FDA 510(k) clearance on 2022-10-07. It is manufactured by Endymed Medical, Ltd.. The 510(k) number is K222369.
When was PURE Laser approved by the FDA?
PURE Laser received FDA 510(k) clearance on 2022-10-07, under approval number K222369.
What company makes PURE Laser?
PURE Laser is manufactured by Endymed Medical, Ltd..
What is the FDA product code for PURE Laser?
The FDA product code for PURE Laser is GEX. This falls under the Gastroenterology category.
Other Devices by Endymed Medical, Ltd.
Related Devices (Code: GEX)
K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.
K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.
K163222Discovery Pico FamilyQuanta System Spa
K163009LithoQuanta System Spa
K162191NAVILAS Laser SystemOd-Os GmbH
K162363V30 system, V-Form Handpiece BC Medium applicatorViora , 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.