Clearance Summary
LIO-714 OPACITYMETER received FDA 510(k) clearance under submission number K790526, sponsored by Laser Industries , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1979-11-16.
- Submission: K790526
- Applicant / Sponsor: Laser Industries , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1380
- Decision date: 1979-11-16
Classification & Regulation
This clearance is catalogued under FDA product code HJL and 21 CFR 886.1380, within the Ophthalmic review panel as a Class I device.