Clearance Summary
3N Contact Lenses Adjunct Cleaner received FDA 510(k) clearance under submission number K211361, sponsored by Suzhou 3N Biological Technology 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 2022-01-13.
- Submission: K211361
- Applicant / Sponsor: Suzhou 3N Biological Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 2022-01-13
Classification & Regulation
This clearance is catalogued under FDA product code LYL and 21 CFR 886.5928, within the Ophthalmic review panel as a Class II device.