Clearance Summary
Marco Ultra M3, Marco Ultra M4 received FDA 510(k) clearance under submission number K162636, sponsored by Takagi Seiko Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2017-04-14.
- Submission: K162636
- Applicant / Sponsor: Takagi Seiko Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 2017-04-14
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.