Clearance Summary
MED-GENESIS PATIENT LASER EYE SHIELD received FDA 510(k) clearance under submission number K934459, sponsored by Med-Genesis, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1994-02-22.
- Submission: K934459
- Applicant / Sponsor: Med-Genesis, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1994-02-22
Classification & Regulation
This clearance is catalogued under FDA product code IWS and 21 CFR 892.6500, within the Radiology review panel as a Class I device.