Clearance Summary
MEDIWORKS SLIT LAMP received FDA 510(k) clearance under submission number K100439, sponsored by Shanghai Mediworks Precision Instruments 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 2010-07-16.
- Submission: K100439
- Applicant / Sponsor: Shanghai Mediworks Precision Instruments Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 2010-07-16
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.