Cleared Traditional

K023045 - MICRORUPTER V (FDA 510(k) Clearance)

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

K023045 · Meridian AG · Ophthalmic device
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Sep 2002
Decision
14d
Days
Class 2
Risk

K023045 is an FDA 510(k) clearance for the MICRORUPTER V. Classified as Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla (product code LXS), Class II - Special Controls.

Submitted by Meridian AG (Thun, Bern, CH). The FDA issued a Cleared decision on September 26, 2002 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4392 - 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 Meridian AG devices

Submission Details

510(k) Number K023045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2002
Decision Date September 26, 2002
Days to Decision 14 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 110d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code LXS Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4392
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.