Cleared Traditional

K150722 - EnFocus 2300, EnFocus 4400 (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K150722 · Bioptigen, Inc. · Ophthalmic device
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Dec 2015
Decision
257d
Days
Class 2
Risk

K150722 is an FDA 510(k) clearance for the EnFocus 2300, EnFocus 4400. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Bioptigen, Inc. (Morrisville, US). The FDA issued a Cleared decision on December 2, 2015 after a review of 257 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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 Bioptigen, Inc. devices

Submission Details

510(k) Number K150722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2015
Decision Date December 02, 2015
Days to Decision 257 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
147d slower than avg
Panel avg: 110d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HLI Ophthalmoscope, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
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.