Clearance Summary
SLIT LAMP, Model: YF-100 received FDA 510(k) clearance under submission number K161764, sponsored by Chongqing Yeasn Science-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 2017-02-16.
- Submission: K161764
- Applicant / Sponsor: Chongqing Yeasn Science-Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 2017-02-16
Classification & Regulation
This clearance is catalogued under FDA product code HJO and 21 CFR 886.1850, within the Ophthalmic review panel as a Class II device.