Clearance Summary
One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series received FDA 510(k) clearance under submission number K143434, sponsored by Abbott Medical Optics, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2015-05-06.
- Submission: K143434
- Applicant / Sponsor: Abbott Medical Optics, Inc.
- Clearance pathway: Abbreviated
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2015-05-06
Classification & Regulation
This clearance is catalogued under FDA product code MSS and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.