Cleared Traditional

K895864 - MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP

K895864 is an FDA 510(k) clearance for MICRORUPTOR III SYST, manufactured by Lasag AG. The device is a Class 2 Ophthalmic device with product code LXS cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K895864 · Lasag AG · Ophthalmic device
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Dec 1989
Decision
87d
Days
Class 2
Risk

K895864 is an FDA 510(k) clearance for the MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP. Classified as Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla (product code LXS), Class II - Special Controls.

Submitted by Lasag AG (Eden Prairie, US). The FDA issued a Cleared decision on December 29, 1989 after a review of 87 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 Lasag AG devices

FDA 510(k) Submission Details - K895864

510(k) Number K895864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1989
Decision Date December 29, 1989
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 110d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LXS Device Classification - Class 2, Special Controls

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.