Clearance Summary
VISION-TECH YZ SLIT LAMP, MODEL 66 received FDA 510(k) clearance under submission number K033190, sponsored by Suzhou 66 Vision-Tech 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 2003-12-04.
- Submission: K033190
- Applicant / Sponsor: Suzhou 66 Vision-Tech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 2003-12-04
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.