Clearance Summary
Contact Lens Case, Model: A-1, B-1 received FDA 510(k) clearance under submission number K172925, sponsored by P L Overseas Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2017-11-30.
- Submission: K172925
- Applicant / Sponsor: P L Overseas Limited
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 2017-11-30
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.