Cleared Traditional

K211643 - Vision Monitor - MonpackONE

K211643 is an FDA 510(k) clearance for Vision Monitor - MonpackONE, manufactured by Metrovision. The device is a Class 2 Ophthalmic device with product code GWE cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K211643 · Metrovision · Ophthalmic device
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Jul 2021
Decision
60d
Days
Class 2
Risk

K211643 is an FDA 510(k) clearance for the Vision Monitor - MonpackONE. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Metrovision (Perenchies, FR). The FDA issued a Cleared decision on July 26, 2021 after a review of 60 days - a notably fast clearance 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: 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 Metrovision devices

FDA 510(k) Submission Details - K211643

510(k) Number K211643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2021
Decision Date July 26, 2021
Days to Decision 60 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
50d faster than avg
Panel avg: 110d · This submission: 60d
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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