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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Laser, Scanning
510(k) Number K261740
Device Name Adaptive Optics Scanning Laser Ophthalmoscope (Mona IV)
Applicant
Robotrak Technologies Co., Ltd.
1f, Bldg. 2, #6 Qiande Rd., Jiangning District
Nanjing,  CN 210000
Applicant Contact Li Zhang
Correspondent
Robotrak Technologies Co., Ltd.
163 Caversham Woods, Pittsford
Pittsford,  NY  14534
Correspondent Contact Jie Zhang
Regulation Number886.1570
Classification Product Code
MYC  
Date Received05/27/2026
Decision Date 10/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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