Clearance Summary
Contact Lens Case received FDA 510(k) clearance under submission number K171539, sponsored by E-Link Plastic & Metal Industrial 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 2017-07-14.
- Submission: K171539
- Applicant / Sponsor: E-Link Plastic & Metal Industrial Co.,Ltd
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 2017-07-14
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.