Cleared Traditional

K132042 - AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND (FDA 510(k) Clearance)

Class I Ophthalmic device.

K132042 · X6d, Ltd. · Ophthalmic device
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Apr 2014
Decision
300d
Days
Class 1
Risk

K132042 is an FDA 510(k) clearance for the AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND. Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by X6d, Ltd. (Zur- Moshe, IL). The FDA issued a Cleared decision on April 28, 2014 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4750 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all X6d, Ltd. devices

Submission Details

510(k) Number K132042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 110d · This submission: 300d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4750
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.