510(k) K243014
K243014 is an FDA 510(k) premarket notification submitted by Eyeq, Inc. for the device "EyeQ nanoECP". The FDA issued a decision of Substantially Equivalent on June 18, 2025. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2025
- Date Received
- September 27, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.4390
- Review Panel
- OP
- Submission Type