Cleared Traditional

K973064 - KEELER TEARSCOPE-PLUS

K973064 is the FDA 510(k) clearance for KEELER TEARSCOPE-PLUS by Keeler Instruments, Inc.. It is a Class 2 Ophthalmic device (product code HJO) cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K973064 · Keeler Instruments, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
232d
Days
Class 2
Risk

K973064 is an FDA 510(k) clearance for the KEELER TEARSCOPE-PLUS. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on April 7, 1998 after a review of 232 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Keeler Instruments, Inc. devices

Submission Details

510(k) Number K973064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1997
Decision Date April 07, 1998
Days to Decision 232 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 110d · This submission: 232d
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 20
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K973064.
IOLMASTER 500
K101182 · Carl Zeiss Meditec, AG · Nov 2010
PSL CLASSIC SLIT LAMP
K100500 · Keeler Instruments, Inc. · Mar 2010
DOCUMENTING LASER SLIT LAMP, DP 2010
K012873 · Bausch & Lomb, Inc. · Nov 2001
SLIT LAMP, H-201
K936209 · Canon USA, Inc. · Apr 1994
OCS 100 (OCULAR COMPARATOR SYSTEM)
K874220 · Ocular Instruments, Inc. · Dec 1987
BAUSCH & LOMB CSL-1000 SLIT LAMP
K862515 · Bausch & Lomb, Inc. · Jul 1986