Cleared Traditional

VX650 (K202221) - FDA 510(k) Clearance

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

K202221 · Luneau Technology Operations · Ophthalmic device
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Jan 2021
Decision
176d
Days
Class 2
Risk

K202221 is an FDA 510(k) clearance for the VX650. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Luneau Technology Operations (Pont-De-L'Arche, FR). The FDA issued a Cleared decision on January 29, 2021 after a review of 176 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - 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 Luneau Technology Operations devices

Submission Details

510(k) Number K202221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2020
Decision Date January 29, 2021
Days to Decision 176 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
66d slower than avg
Panel avg: 110d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
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 - HKI Camera, Ophthalmic, Ac-powered

All 34
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K202221.
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Optomed Smartscope M5 with Optomed Smartscope FA
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Canon non-mydriatic retinal camera CR series
K201122 · Canon, Inc. · Jul 2020
XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
K193319 · Vasoptic Medical, Inc. · Jun 2020