Clearance Summary
SUNTOUCH EYE SPEAR received FDA 510(k) clearance under submission number K132796, sponsored by Huizhou Foryou Medical Devices 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 2013-10-30.
- Submission: K132796
- Applicant / Sponsor: Huizhou Foryou Medical Devices Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4790
- Decision date: 2013-10-30
Classification & Regulation
This clearance is catalogued under FDA product code HOZ and 21 CFR 886.4790, within the Ophthalmic review panel as a Class II device.