Dental 5 Multi Diode laser
K-Number: K163638 · 2017-05-15
ApplicantBio-Med USA, Inc.
Decision Date2017-05-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Dental 5 Multi Diode laser is a medical device manufactured by Bio-Med USA, Inc.. It received FDA 510(k) clearance on 2017-05-15 under approval number K163638. 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 Dental 5 Multi Diode laser?
Dental 5 Multi Diode laser is a medical device that received FDA 510(k) clearance on 2017-05-15. It is manufactured by Bio-Med USA, Inc.. The 510(k) number is K163638.
When was Dental 5 Multi Diode laser approved by the FDA?
Dental 5 Multi Diode laser received FDA 510(k) clearance on 2017-05-15, under approval number K163638.
What company makes Dental 5 Multi Diode laser?
Dental 5 Multi Diode laser is manufactured by Bio-Med USA, Inc..
What is the FDA product code for Dental 5 Multi Diode laser?
The FDA product code for Dental 5 Multi Diode laser is GEX. This falls under the Gastroenterology category.
Related Clinical Trials
NCT07607028
Comparison of Ultrasonic vs 980-nm Diode Laser Irrigant Activation for Reducing Residual Bacterial DNA in Necrotic Teeth
COMPLETED
NCT07101809
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
RECRUITING
NCT07593508
Diode Laser-Assisted Direct Pulp Capping Trial
COMPLETED
NCT05883202
Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants
SUSPENDED
NCT06960161
Exploring the Use of Phototherapy to Improve CPAP Compliance
RECRUITING
NCT07278999
Photobiomodulation, Photodynamic Therapy, and Clobetasol in the Treatment of Oral Lichen Planus.
RECRUITING
Other Devices by Bio-Med USA, 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.