EdgePro— 510(k) K213428

Substantially Equivalent

Biolase, Inc.

FDA 510(k) clearance K213428 for EdgePro, Substantially Equivalent on 2021-12-22. Applicant: Biolase, Inc..

Clearance details

Applicant: Biolase, Inc.
Product code: Code NVK
Advisory panel: General, Plastic Surgery
Date received: 2021-10-21
Decision date: 2021-12-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Foothill Ranch, CA, US

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