510(k) K243851
K243851 is an FDA 510(k) premarket notification submitted by Fairtility , Ltd. for the device "CHLOE BLAST". The FDA issued a decision of Substantially Equivalent on August 15, 2025. The device falls under product code PBH (Embryo Image Assessment System, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6195.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2025
- Date Received
- December 16, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Embryo Image Assessment System, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6195
- Review Panel
- OB
- Submission Type
The device will obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing .