Cleared Traditional

EYE GARD

K872000 · Treace Medical, Inc. · Ophthalmic

Jul 1987

Decision

56d

Days

Class 1

Risk

About This 510(k) Submission

K872000 is an FDA 510(k) clearance for the EYE GARD, a Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (Class I — General Controls, product code HOY), submitted by Treace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on July 21, 1987, 56 days after receiving the submission on May 26, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4750.

Submission Details

510(k) Number	K872000 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 26, 1987
Decision Date	July 21, 1987
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—

Device Classification

Product Code	HOY — Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Device Class	Class I — General Controls
CFR Regulation	21 CFR 886.4750