Clearance Summary
Portable Slit Lamp received FDA 510(k) clearance under submission number K153545, sponsored by Shanghai Bolan Optical-Electric 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 2016-06-22.
- Submission: K153545
- Applicant / Sponsor: Shanghai Bolan Optical-Electric Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 2016-06-22
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.