AviClear Laser System
K-Number: K251149 · 2025-07-11
ApplicantCutera, Inc.
Decision Date2025-07-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
AviClear Laser System is a medical device manufactured by Cutera, Inc.. It received FDA 510(k) clearance on 2025-07-11 under approval number K251149. 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 AviClear Laser System?
AviClear Laser System is a medical device that received FDA 510(k) clearance on 2025-07-11. It is manufactured by Cutera, Inc.. The 510(k) number is K251149.
When was AviClear Laser System approved by the FDA?
AviClear Laser System received FDA 510(k) clearance on 2025-07-11, under approval number K251149.
What company makes AviClear Laser System?
AviClear Laser System is manufactured by Cutera, Inc..
What is the FDA product code for AviClear Laser System?
The FDA product code for AviClear Laser System is GEX. This falls under the Gastroenterology category.
Related Clinical Trials
NCT07607496
MacuTherm Performance Study in Patients With iAMD
NOT_YET_RECRUITING
NCT07101809
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
RECRUITING
NCT07214220
Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation
RECRUITING
NCT07580560
Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study
COMPLETED
NCT06795451
Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains
RECRUITING
NCT07340671
Facial Papules in Frontal Fibrosing Alopecia (FFA)
NOT_YET_RECRUITING
Related PubMed Literature
Other Devices by Cutera, Inc.
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.