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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K261602
Device Name Eye Recovery Pro (PH-e03)
Applicant
Shenzhen Goodwind Technology Development Co., Ltd.
Rm. 801, Bldg. 1, Baolong Intelligent Manufacturing Park, #
Shenzhen,  CN 518116
Applicant Contact Ziming Yang
Correspondent
Shenzhen Goodwind Technology Development Co., Ltd.
Rm. 801, Bldg. 1, Baolong Intelligent Manufacturing Park, #
Shenzhen,  CN 518116
Correspondent Contact Ziming Yang
Regulation Number878.4810
Classification Product Code
OHS  
Date Received05/14/2026
Decision Date 08/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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