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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K251920
Device Name Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask
Applicant
Dcstar, Inc.
228 Park Ave. S 30327
New York,  NY  10003
Applicant Contact Leo Liu
Correspondent
Dcstar, Inc.
228 Park Ave. S 30327
New York,  NY  10003
Correspondent Contact Emma Chan
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/23/2025
Decision Date 05/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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