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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K230342
Device Name Phototherapy System (OL-PDT950)
Applicant
Shanghai Omni Laser Skinology Co., Ltd.
Floor 3, Bldg. 3, #227, Mingqiang Rd.
Songjiang District
Shanghai,  CN 201612
Applicant Contact Avril Ouyang
Correspondent
New Risen Enterprise Management Consulting Co.,Ltd
Rm. 302, Bldg. 3, Hangqian Mansion
Hangqian St., Lucheng District
Wenzhou,  CN 325000
Correspondent Contact Helen Nan
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/08/2023
Decision Date 08/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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