Cleared Traditional

K231011 - Merilas 532 shortpulse

K231011 is an FDA 510(k) clearance for Merilas 532 shortpulse, manufactured by Meridian AG. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K231011 · Meridian AG · Ophthalmic device
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Sep 2023
Decision
155d
Days
Class 2
Risk

K231011 is an FDA 510(k) clearance for the Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Meridian AG (Thun, CH). The FDA issued a Cleared decision on September 12, 2023 after a review of 155 days - an extended review cycle.

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 Meridian AG devices

FDA 510(k) Submission Details - K231011

510(k) Number K231011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2023
Decision Date September 12, 2023
Days to Decision 155 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 110d · This submission: 155d
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 K231011.
Eagle device
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K230350 · Carl Zeiss Meditec, Inc. · Sep 2023
Iridex 532 Laser
K230228 · Iridex Corporation · Feb 2023
R:GEN
K220974 · Lutronic Vision, Inc. · Dec 2022
Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)
K223132 · Iridex Corporation · Nov 2022