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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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