Clearance Summary
CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS received FDA 510(k) clearance under submission number K080632, sponsored by Clearlab SG Pte, 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 2008-10-15.
- Submission: K080632
- Applicant / Sponsor: Clearlab SG Pte, Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2008-10-15
Classification & Regulation
This clearance is catalogued under FDA product code MVN and 21 CFR 886.5925, within the Ophthalmic review panel as a Class II device.