Clearance Summary
RS-1000 ZOOM SLITLAMP WITH OPTION received FDA 510(k) clearance under submission number K060869, sponsored by Rightmedical Products, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2006-05-11.
- Submission: K060869
- Applicant / Sponsor: Rightmedical Products, LLC
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 2006-05-11
Classification & Regulation
This clearance is catalogued under FDA product code HJO and 21 CFR 886.1850, within the Ophthalmic review panel as a Class II device.