510(k) K143086
K143086 is an FDA 510(k) premarket notification submitted by Luneau Sas for the device "VX120 Ophthalmic Diagnostic Device". The FDA issued a decision of Substantially Equivalent on June 1, 2015. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Luneau Sas has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 2015
- Date Received
- October 27, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tonometer, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1930
- Review Panel
- OP
- Submission Type