Clearance Summary
LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA received FDA 510(k) clearance under submission number K001772, sponsored by Taracan Pty. , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2000-07-06.
- Submission: K001772
- Applicant / Sponsor: Taracan Pty. , Ltd.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 2000-07-06
Classification & Regulation
This clearance is catalogued under FDA product code HQF and 21 CFR 886.4390, within the Ophthalmic review panel as a Class II device.