Clearance Summary
Contact Lens Case received FDA 510(k) clearance under submission number K162869, sponsored by Ningbo Yinzhou Zonghai Artware 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 2016-12-09.
- Submission: K162869
- Applicant / Sponsor: Ningbo Yinzhou Zonghai Artware Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 2016-12-09
Classification & Regulation
This clearance is catalogued under FDA product code LRX and 21 CFR 886.5928, within the Ophthalmic review panel as a Class II device.