Clearance Summary
AUTOMATED CORNEAL TREPHINE received FDA 510(k) clearance under submission number K981063, sponsored by Laser Center Dev. Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1998-06-23.
- Submission: K981063
- Applicant / Sponsor: Laser Center Dev. Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4070
- Decision date: 1998-06-23
Classification & Regulation
This clearance is catalogued under FDA product code HRG and 21 CFR 886.4070, within the Ophthalmic review panel as a Class I device.