Gemini NOVA 810+980 Soft Tissue Laser— 510(k) K260765

Name: FDA 510(k) clearance K260765
Creator: U.S. Food and Drug Administration
Published: 2026-03-10

Substantially Equivalent

Azena Medical, LLC

FDA 510(k) clearance K260765 for Gemini NOVA 810+980 Soft Tissue Laser, Substantially Equivalent on 2026-03-10. Applicant: Azena Medical, LLC. Device class: 2.

Clearance details

Applicant: Azena Medical, LLC
Product code: Code NVK
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2026-03-09
Decision date: 2026-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.