510(k) clearance
Adaptive Optics Scanning Laser Ophthalmoscope (Mona IV)
- 510(k) number
- K261740
- Applicant
- Robotrak Technologies Co., Ltd.
- Decision date
- Oct 27, 2026
- Date received
- May 27, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MYC
- Device type
- Ophthalmoscope, Laser, Scanning
- Device class
- Class II
- Regulation
- 21 CFR 886.1570
- Advisory committee
- Ophthalmic
- Statement or summary
- Summary
- Third party
- N
- Location
- Nanjing, CN