Cleared Traditional

K232051 - VISULAS green

K232051 is an FDA 510(k) clearance for VISULAS green, manufactured by Carl Zeiss Meditec. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K232051 · Carl Zeiss Meditec · Ophthalmic device
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Oct 2023
Decision
106d
Days
Class 2
Risk

K232051 is an FDA 510(k) clearance for the VISULAS green. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Carl Zeiss Meditec (Dublin, US). The FDA issued a Cleared decision on October 24, 2023 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - 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 Carl Zeiss Meditec devices

FDA 510(k) Submission Details - K232051

510(k) Number K232051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2023
Decision Date October 24, 2023
Days to Decision 106 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
4d faster than avg
Panel avg: 110d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQF Device Classification - Class 2, Special Controls

Product Code HQF Laser, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
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 - HQF Laser, Ophthalmic

All 83
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K232051.
VISULAS combi
K233911 · Carl Zeiss Meditec, AG · Sep 2024
MR Q
K232417 · Meridian AG · Jan 2024
Eagle device
K230722 · Belkin Vision, Ltd. · Dec 2023
VISULAS yag
K230350 · Carl Zeiss Meditec, Inc. · Sep 2023
Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse
K231011 · Meridian AG · Sep 2023
Iridex 532 Laser
K230228 · Iridex Corporation · Feb 2023