Clearance Summary
SLM-1ER, SLM-2ER, SLM-3ER received FDA 510(k) clearance under submission number K171877, sponsored by Chongqing Kanghua Ruiming S&T 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 2017-12-21.
- Submission: K171877
- Applicant / Sponsor: Chongqing Kanghua Ruiming S&T Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 2017-12-21
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.