EdgePro
K-Number: K213428 · 2021-12-22
Device Summary
Frequently Asked Questions
What is the EdgePro?
EdgePro is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Biolase, Inc.. The 510(k) number is K213428.
When did EdgePro receive FDA 510(k) clearance?
EdgePro received FDA 510(k) clearance on 2021-12-22, under 510(k) number K213428.
Who is the listed applicant for EdgePro?
The FDA 510(k) record lists Biolase, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EdgePro?
The FDA product code for EdgePro is NVK.
Other records listing Biolase, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: NVK)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.