Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Powered Laser Surgical Instrument
510(k) Number K254271
Device Name CAPRI
Applicant
ORO Co., Ltd.
707, 708, 709, Geumgwang High-Tech City 789
Taejang-Ro, Gimpo-Si, Gyeonggi-Do, Republic Of Korea
Gimpo-Si,  KR 10091
Applicant Contact James Hoon Lim
Correspondent
ORO Co., Ltd.
707, 708, 709, Geumgwang High-Tech City 789
Taejang-Ro, Gimpo-Si, Gyeonggi-Do, Republic Of Korea
Gimpo-Si,  KR 10091
Correspondent Contact James Hoon Lim
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/30/2025
Decision Date 02/26/2026
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
-
-