Cleared Traditional

K142423 - EyeSuite Imaging

K142423 is an FDA 510(k) clearance for EyeSuite Imaging, manufactured by Haag-Streit AG. The device is a Class 2 Ophthalmic device with product code NFJ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K142423 · Haag-Streit AG · Ophthalmic device
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Sep 2014
Decision
13d
Days
Class 2
Risk

K142423 is an FDA 510(k) clearance for the EyeSuite Imaging. Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Haag-Streit AG (Koeniz, Bern, CH). The FDA issued a Cleared decision on September 10, 2014 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 892.2050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Haag-Streit AG devices

FDA 510(k) Submission Details - K142423

510(k) Number K142423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2014
Decision Date September 10, 2014
Days to Decision 13 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 110d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

NFJ Device Classification - Class 2, Special Controls

Product Code NFJ System, Image Management, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - NFJ System, Image Management, Ophthalmic

All 35
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