Cleared Special

K162783 - EnFocus 2300, EnFocus 4400 (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K162783 · Bioptigen, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
67d
Days
Class 2
Risk

K162783 is an FDA 510(k) clearance for the EnFocus 2300, EnFocus 4400. Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Bioptigen, Inc. (Morrisville, US). The FDA issued a Cleared decision on December 9, 2016 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bioptigen, Inc. devices

Submission Details

510(k) Number K162783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2016
Decision Date December 09, 2016
Days to Decision 67 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 110d · This submission: 67d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OBO Tomography, Optical Coherence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
Definition Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases.
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 - OBO Tomography, Optical Coherence

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