Clearance Summary
MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE received FDA 510(k) clearance under submission number K844668, sponsored by Cooper Lasersonics, 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 1985-01-03.
- Submission: K844668
- Applicant / Sponsor: Cooper Lasersonics, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 1985-01-03
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.