Cleared Traditional

K221471 - E3 and Profile

K221471 is an FDA 510(k) clearance for E3 and Profile, manufactured by Diagnosys, LLC. The device is a Class 2 Ophthalmic device with product code GWE cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K221471 · Diagnosys, LLC · Ophthalmic device
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Nov 2022
Decision
186d
Days
Class 2
Risk

K221471 is an FDA 510(k) clearance for the E3 and Profile. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Diagnosys, LLC (Lowell, US). The FDA issued a Cleared decision on November 22, 2022 after a review of 186 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 882.1890 - 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 Diagnosys, LLC devices

FDA 510(k) Submission Details - K221471

510(k) Number K221471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2022
Decision Date November 22, 2022
Days to Decision 186 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 110d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWE Device Classification - Class 2, Special Controls

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
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 - GWE Stimulator, Photic, Evoked Response

All 20
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