Cleared Traditional

K930518 - TALIA LASER SLIT

K930518 is an FDA 510(k) clearance for TALIA LASER SLIT, manufactured by Talia Technology , Ltd.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 358-day FDA review.

K930518 · Talia Technology , Ltd. · Ophthalmic device
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Jan 1994
Decision
358d
Days
Class 2
Risk

K930518 is an FDA 510(k) clearance for the TALIA LASER SLIT. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Talia Technology , Ltd. (Washington, D.C., US). The FDA issued a Cleared decision on January 25, 1994 after a review of 358 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 Talia Technology , Ltd. devices

FDA 510(k) Submission Details - K930518

510(k) Number K930518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1993
Decision Date January 25, 1994
Days to Decision 358 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
248d slower than avg
Panel avg: 110d · This submission: 358d
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 52
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K930518.
NEITZ SLIT LAMP SL-H2
K951341 · Neitz Instruments Company, Ltd. · Jun 1995
NEITZ SLIT LAMP SL-H1
K951340 · Neitz Instruments Company, Ltd. · Apr 1995
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K936209 · Canon USA, Inc. · Apr 1994
ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR
K925641 · Carl Zeiss, Inc. · Sep 1993
BURTON SLIT LAMP - MODEL 850
K924783 · R.H. Burton Co. · Apr 1993
BURTON HAND HELD SLIT LAMP - MODEL SL750
K924770 · R.H. Burton Co. · Jan 1993