Cleared Traditional

AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND

K132042 · X6d, Ltd. · Ophthalmic

Apr 2014

Decision

300d

Days

Class 1

Risk

About This 510(k) Submission

K132042 is an FDA 510(k) clearance for the AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND, a Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (Class I — General Controls, product code HOY), submitted by X6d, Ltd. (Zur- Moshe, IL). The FDA issued a Cleared decision on April 28, 2014, 300 days after receiving the submission on July 2, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4750.

Submission Details

510(k) Number	K132042 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 2013
Decision Date	April 28, 2014
Days to Decision	300 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

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