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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Dental, Soft Tissue
510(k) Number K210367
Device Name D-Laser Blue, D-Laser 16
Applicant
Guilin Woodpecker Medical Instrument Co., Ltd.
Information Industrial Park, Guilin National High-Tech Zone
Guilin,  CN 541004
Applicant Contact Yang Yunfeng
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian
Avenue, Xili Town, Nanshan District
Shenzhen,  CN 518055
Correspondent Contact Fu Ailing
Regulation Number878.4810
Classification Product Code
NVK  
Subsequent Product Codes
GEX   ILY  
Date Received02/08/2021
Decision Date 03/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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