Clearance Summary
Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA received FDA 510(k) clearance under submission number K181230, sponsored by Largan Medical 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 2018-06-25.
- Submission: K181230
- Applicant / Sponsor: Largan Medical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2018-06-25
Classification & Regulation
This clearance is catalogued under FDA product code LPL and 21 CFR 886.5925, within the Ophthalmic review panel as a Class II device.