Cleared Traditional

K954782 - KOWA PORTABLE SLIT LAMP SL-14 & SL-14B

K954782 is the FDA 510(k) clearance for KOWA PORTABLE SLIT LAMP SL-14 & SL-14B by Kowa Optimed, Inc.. It is a Class 2 Ophthalmic device (product code HJO) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K954782 · Kowa Optimed, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
38d
Days
Class 2
Risk

K954782 is an FDA 510(k) clearance for the KOWA PORTABLE SLIT LAMP SL-14 & SL-14B. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Kowa Optimed, Inc. (Washington, US). The FDA issued a Cleared decision on November 24, 1995 after a review of 38 days - a notably fast clearance cycle.

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: 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 Kowa Optimed, Inc. devices

Submission Details

510(k) Number K954782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1995
Decision Date November 24, 1995
Days to Decision 38 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
72d faster than avg
Panel avg: 110d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K954782.
DOCUMENTING LASER SLIT LAMP, DP 2010
K012873 · Bausch & Lomb, Inc. · Nov 2001
IOLMASTER
K993357 · Carl Zeiss, Inc. · Mar 2000
KEELER TEARSCOPE-PLUS
K973064 · Keeler Instruments, Inc. · Apr 1998
SLIT LAMP, H-201
K936209 · Canon USA, Inc. · Apr 1994
ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR
K925641 · Carl Zeiss, Inc. · Sep 1993
ZEISS 40 SL/P PHOTO SLIT LAMP
K874160 · Carl Zeiss, Inc. · Jan 1988