Clearance Summary
KROM-X LENS SYSTEM received FDA 510(k) clearance under submission number K865103, sponsored by Neo Optics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1987-01-20.
- Submission: K865103
- Applicant / Sponsor: Neo Optics, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5844
- Decision date: 1987-01-20
Classification & Regulation
This clearance is catalogued under FDA product code HQG and 21 CFR 886.5844, within the Ophthalmic review panel as a Class I device.