510(k) clearances

Adaptive Optics Scanning Laser Ophthalmoscope (Mona IV)

Robotrak Technologies Co., Ltd. · Ophthalmic

K261740Substantially EquivalentTraditionalMYC
Open FDA's page for this record
Third party flag
N
City
Nanjing
Advisory committee description
Ophthalmic
Address 1
1f, Bldg. 2, #6 Qiande Rd., Jiangning District
Statement or summary
Summary
Product code
MYC
Zip code
210000
Applicant
Robotrak Technologies Co., Ltd.
Decision date
2026-10-27
Decision code
SESE
Country code
CN
Device name
Adaptive Optics Scanning Laser Ophthalmoscope (Mona IV)
Advisory committee
OP
Contact
Li Zhang
K number
K261740
Date received
2026-05-27
Review advisory committee
OP
Postal code
210000
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Ophthalmoscope, Laser, Scanning
Medical specialty description
Ophthalmic
Regulation number
886.1570
Device class
2
Registration number
3005744933, 3013403214, 2080939, 3008348697, 2936921, 9617167, 3009973692, 3017133887, 3008422902, 3002807715, 8030392, 3010394097, 8043762, 2918630, 3043126966, 3011223751
FEI number
3005744933, 3013403214, 3002807157, 2080939, 3008348697, 2936921, 3009973692, 3017133887, 3010394097, 3002807715, 3008422902, 3003060634, 2918630, 3043126966, 3011223751
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.