Cleared Traditional

K132042 - AMB101 SYSTEM

K132042 is an FDA 510(k) clearance for AMB101 SYSTEM, manufactured by X6d, Ltd.. The device is a Class 1 Ophthalmic device with product code HOY cleared through the Traditional 510(k) pathway after a 300-day FDA review.

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

FDA 510(k) Submission Details - K132042

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.

HOY Device Classification - Class 1, General Controls

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.

Regulatory Peers - HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)

All 12
Devices cleared under the same product code (HOY) and FDA review panel - the closest regulatory comparables to K132042.
SHAIDS PROTECTIVE GLASSES
K930347 · Depuy, Inc. · Apr 1994
MODIFICATION OF SURGICAL EYESHIELD MASK
K934085 · American Threshold Industries, Inc. · Nov 1993
EYE BUBBLE
K912367 · Aaron Medical Industries · Oct 1991
UNIDIRECTIONAL OCCLUDER
K913230 · Welch Allyn, Inc. · Oct 1991
SOFT CORNEAL LIGHT SHIELD
K896681 · Visitec Co. · Jan 1990
HEALTH CARE EYE PROTECTION
K875107 · Surgikos, Inc. · Mar 1988