Align Studio— 510(k) K232564

Substantially Equivalent

Laon Medi, Inc.

FDA 510(k) clearance K232564 for Align Studio, Substantially Equivalent on 2024-03-12. Applicant: Laon Medi, Inc.. Device class: 2.

Clearance details

Applicant
Laon Medi, Inc.
Product code
Code PNN
Device class
Class 2
Regulation
21 CFR 872.5470
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Seongnam-Si, KR
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