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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K262822
Device Name Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401)
Applicant
Zhongshan GL Electronics Co. , Ltd.
3-5th Floor, Wanhua Bldg., #20, Dehe Rd., Jidongyi, Xiaolan
Zhongshan,  CN 528416
Applicant Contact Cassie Gao
Correspondent
Zhongshan GL Electronics Co. , Ltd.
3-5th Floor, Wanhua Bldg., #20, Dehe Rd., Jidongyi, Xiaolan
Zhongshan,  CN 528416
Correspondent Contact Cassie Gao
Regulation Number878.4780
Classification Product Code
BTA  
Date Received08/10/2026
Decision Date 10/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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