510(k) K251353
K251353 is an FDA 510(k) premarket notification submitted by Phelcom Technologies for the device "Eyer 2". The FDA issued a decision of Substantially Equivalent on January 16, 2026. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Phelcom Technologies has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 2026
- Date Received
- April 30, 2025
- 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