Cleared Traditional

K953965 - 904 SLIT LAMP

K953965 is an FDA 510(k) clearance for 904 SLIT LAMP, manufactured by Clement Clarke, Inc.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K953965 · Clement Clarke, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
36d
Days
Class 2
Risk

K953965 is an FDA 510(k) clearance for the 904 SLIT LAMP. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Clement Clarke, Inc. (England, GB). The FDA issued a Cleared decision on September 27, 1995 after a review of 36 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.

FDA 510(k) Submission Details - K953965

510(k) Number K953965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1995
Decision Date September 27, 1995
Days to Decision 36 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 110d · This submission: 36d
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 103
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K953965.
RODENSTOCK SLITLAMP (MODEL 5000 & 4000)
K962532 · Expertech Assoc., Inc. · Jul 1996
KOWA PORTABLE SLIT LAMP SL-14 & SL-14B
K954782 · Kowa Optimed, Inc. · Nov 1995
BOBES SLIT LAMP
K945445 · Bobes S.A. · Oct 1995
SLIT LAMP AIA 11
K953030 · Naveen Intl., Inc. · Jul 1995
NEITZ SLIT LAMP SL-H2
K951341 · Neitz Instruments Company, Ltd. · Jun 1995
OTI MODEL 78-60
K951184 · Oti Medical, LLC · May 1995
K953965 · 904 SLIT LAMP
Download PDF FDA Summary Clement Clarke, Inc.