Clearance Summary
ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 received FDA 510(k) clearance under submission number K081545, sponsored by Advanced Medical Optics, 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 2008-10-02.
- Submission: K081545
- Applicant / Sponsor: Advanced Medical Optics, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2008-10-02
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.