Cleared Traditional

K082891 - LENSTAR

K082891 is an FDA 510(k) clearance for LENSTAR, manufactured by Haag-Streit AG. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K082891 · Haag-Streit AG · Ophthalmic device
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Oct 2009
Decision
385d
Days
Class 2
Risk

K082891 is an FDA 510(k) clearance for the LENSTAR, MODEL LS900. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Haag-Streit AG (Wadsworth, US). The FDA issued a Cleared decision on October 20, 2009 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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. Elevated predicate reliance profile. 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 Haag-Streit AG devices

FDA 510(k) Submission Details - K082891

510(k) Number K082891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2008
Decision Date October 20, 2009
Days to Decision 385 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
275d slower than avg
Panel avg: 110d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJO Device Classification - Class 2, Special Controls

Product Code HJO Biomicroscope, Slit-lamp, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
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 - HJO Biomicroscope, Slit-lamp, Ac-powered

All 39
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K082891.
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