510(k) K261312
K261312 is an FDA 510(k) premarket notification submitted by Eyekon Medical, Inc. for the device "Temporary Keratoprosthesis (QuickSet TKP)". The FDA issued a decision of Substantially Equivalent on July 24, 2026. The device falls under product code MLP (Keratoprosthesis, Temporary Implant, Surgical Use), a Class II device regulated under 21 CFR 886.3400.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2026
- Date Received
- April 21, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Keratoprosthesis, Temporary Implant, Surgical Use
- Device Class
- Class II
- Regulation Number
- 886.3400
- Review Panel
- OP
- Submission Type