Clearance Summary
NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) received FDA 510(k) clearance under submission number K040913, sponsored by Bausch & Lomb. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2004-07-23.
- Submission: K040913
- Applicant / Sponsor: Bausch & Lomb
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 2004-07-23
Classification & Regulation
This clearance is catalogued under FDA product code MXK and 21 CFR 886.1850, within the Ophthalmic review panel as a Class II device.