510(k) K132796

SUNTOUCH EYE SPEAR by Huizhou Foryou Medical Devices Co., Ltd. — Product Code HOZ

K132796 is an FDA 510(k) premarket notification submitted by Huizhou Foryou Medical Devices Co., Ltd. for the device "SUNTOUCH EYE SPEAR". The FDA issued a decision of Substantially Equivalent on October 30, 2013. The device falls under product code HOZ (Sponge, Ophthalmic), a Class II device regulated under 21 CFR 886.4790. Huizhou Foryou Medical Devices Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2013
Date Received
September 6, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sponge, Ophthalmic
Device Class
Class II
Regulation Number
886.4790
Review Panel
OP
Submission Type