FDA · official record K250482Substantially Equivalent

Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue

Name: Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue — FDA K250482
Creator: Fissiontech, LLC
Keywords: Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue, Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue, K250482, LRK, FDA

United StatesLRKFissiontech, LLC

Verified

Official record identity

FDA application number: K250482
Decision date: May 08, 2025
Published decision: Substantially Equivalent

Classification

Product code: LRK

Published parties

Applicant: Fissiontech, LLC

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2025-02-19
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.5570

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.