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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 K253342
Device Name PICO-K
Applicant
Speclipse, Inc.
#501, #502, #503, #504, #505, 232, Sandan-Ro, Danwon-Gu,
Ansan-Si
Gyeonggi-Do,  KR 15433
Applicant Contact Myung Seo Park
Correspondent
Speclipse, Inc.
#501, #502, #503, #504, #505, 232, Sandan-Ro, Danwon-Gu,
Ansan-Si
Gyeonggi-Do,  KR 15433
Correspondent Contact Myung Seo Park
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/30/2025
Decision Date 12/24/2025
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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