Cleared Traditional

K202221 - VX650

K202221 is an FDA 510(k) clearance for VX650, manufactured by Luneau Technology Operations. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 176-day FDA review.

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

FDA 510(k) Submission Details - K202221

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.

HKI Device Classification - Class 2, Special Controls

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 59
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K202221.
RetCam Envision
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Fundus Camera
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Optomed Smartscope M5 with Optomed Smartscope FA
K201325 · Optomed Oyj · Nov 2020
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