Cleared Traditional

K143123 - Synergetics PHOTON EX

K143123 is an FDA 510(k) clearance for Synergetics PHOTON EX, manufactured by Synergetics. The device is a Class 2 Ophthalmic device with product code MPA cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K143123 · Synergetics · Ophthalmic device
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Feb 2015
Decision
116d
Days
Class 2
Risk

K143123 is an FDA 510(k) clearance for the Synergetics PHOTON EX. Classified as Endoilluminator (product code MPA), Class II - Special Controls.

Submitted by Synergetics (O' Fallon, US). The FDA issued a Cleared decision on February 24, 2015 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 876.1500 - 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 Synergetics devices

FDA 510(k) Submission Details - K143123

510(k) Number K143123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2014
Decision Date February 24, 2015
Days to Decision 116 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
6d slower than avg
Panel avg: 110d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MPA Device Classification - Class 2, Special Controls

Product Code MPA Endoilluminator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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.

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All 10
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