Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

F65 Laser System

K-Number: K222790 · 2023-06-14

ApplicantLumenis Be, Ltd.
Decision Date2023-06-14
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

F65 Laser System is a medical device manufactured by Lumenis Be, Ltd.. It received FDA 510(k) clearance on 2023-06-14 under approval number K222790. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F65 Laser System?

F65 Laser System is a medical device that received FDA 510(k) clearance on 2023-06-14. It is manufactured by Lumenis Be, Ltd.. The 510(k) number is K222790.

When was F65 Laser System approved by the FDA?

F65 Laser System received FDA 510(k) clearance on 2023-06-14, under approval number K222790.

What company makes F65 Laser System?

F65 Laser System is manufactured by Lumenis Be, Ltd..

What is the FDA product code for F65 Laser System?

The FDA product code for F65 Laser System is OAP.

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

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

Other Devices by Lumenis Be, Ltd.

K220467The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories K233301ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories K242349FoLix K250809Stellar M22

Related Devices (Code: OAP)

K162994Capillus302, Capillus312, Capillus352Capillus, LLC K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. K160728NutraStim Hair Laser HelmetNutra Luxe MD, LLC K161046Laser Helmet LH40-EVOTheradome, Inc. K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC K152587DermaScalp Laser CapDermascalp, LLC

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.

↑