510(k) K180306
K180306 is an FDA 510(k) premarket notification submitted by Next Sight Srl for the device "Nexy". The FDA issued a decision of Substantially Equivalent on Jun 8, 2018. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 8, 2018
- Date Received
- Feb 2, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Ophthalmic, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1120
- Review Panel
- OP
- Submission Type
- 510(k)