Cleared Traditional

SUNTOUCH EYE SPEAR

K132796 · Huizhou Foryou Medical Devices Co., Ltd. · Ophthalmic
Oct 2013
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K132796 is an FDA 510(k) clearance for the SUNTOUCH EYE SPEAR, a Sponge, Ophthalmic (Class II — Special Controls, product code HOZ), submitted by Huizhou Foryou Medical Devices Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 30, 2013, 54 days after receiving the submission on September 6, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4790.

Submission Details

510(k) Number K132796 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2013
Decision Date October 30, 2013
Days to Decision 54 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HOZ — Sponge, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4790

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