Cleared Traditional

K152851 - BrainPort V100

K152851 is an FDA 510(k) clearance for BrainPort V100, manufactured by Wicab, Inc.. The device is a Class 2 Ophthalmic device with product code PIC cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K152851 · Wicab, Inc. · Ophthalmic device
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Dec 2015
Decision
86d
Days
Class 2
Risk

K152851 is an FDA 510(k) clearance for the BrainPort V100. Classified as Oral Electronic Vision Aid (product code PIC), Class II - Special Controls.

Submitted by Wicab, Inc. (Middleton, US). The FDA issued a Cleared decision on December 24, 2015 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5905 - 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 Wicab, Inc. devices

FDA 510(k) Submission Details - K152851

510(k) Number K152851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2015
Decision Date December 24, 2015
Days to Decision 86 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
24d faster than avg
Panel avg: 110d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PIC Device Classification - Class 2, Special Controls

Product Code PIC Oral Electronic Vision Aid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5905
Definition To Use As An Oral Electronic Vision Aid In Conjunction With Other Assistive Devices (e.g., The White Cane, Guide Dog, Etc.)
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 Consultant

Hogan Lovells US LLP
STEVEN B DATLOF

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.