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

Biolase, Inc.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories2
Latest FDA decision2022-04-21
TypeNumberDevice NameCodeDateActions
510(k) K210183 Waterlase iPLusGEX2022-04-21 View
510(k) K213428 EdgeProNVK2021-12-22 View
510(k) K193486 Epic 980GEX2020-03-16 View
510(k) K192430 Epic 980GEX2019-12-04 View
510(k) K190319 Waterlase Laser System FamilyGEX2019-10-10 View
510(k) K172771 Epic Pro 940GEX2017-11-29 View
510(k) K163128 Epic ProGEX2017-01-11 View
510(k) K161669 Waterlase ExpressGEX2016-07-28 View

Related Clinical Trials

NCT05555043Comparison of Clinical Outcomes Between GentleWave® and Biolase®COMPLETEDNCT07747350Comparison Between the Effectiveness of Low-Grade Laser Therapy vs. Conventional Analgesics for Pain Reduction During Orthodontic Treatment in Malay Female PopulationRECRUITING
↑