AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND— 510(k) K132042

Name: FDA 510(k) clearance K132042
Creator: U.S. Food and Drug Administration
Published: 2014-04-28

Substantially Equivalent

X6d, Ltd.

FDA 510(k) clearance K132042 for AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND, Substantially Equivalent on 2014-04-28. Applicant: X6d, Ltd.. Device class: 1.

Clearance details

Applicant: X6d, Ltd.
Product code: Code HOY
Device class: Class 1
Regulation: 21 CFR 886.4750
Advisory panel: Ophthalmic
Date received: 2013-07-02
Decision date: 2014-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zur- Moshe, IL

Download summary PDF View on FDA.gov ↗

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