Cleared Traditional

K973064 - KEELER TEARSCOPE-PLUS

K973064 is an FDA 510(k) clearance for KEELER TEARSCOPE-PLUS, manufactured by Keeler Instruments, Inc.. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K973064

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.

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 57
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K973064.
IOLMASTER
K993357 · Carl Zeiss, Inc. · Mar 2000
SL990, SL980, SL950
K992836 · Cso · Nov 1999
BC 900 SLIT LAMP
K982057 · Haag-Streit AG · Aug 1998
AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08
K974467 · Aesculap-Meditec North America · Feb 1998
CONFOSCAN
K971953 · Tomey Corporation USA · Aug 1997
CONFOCAL MICROSCOPE
K970414 · Con-S , Ltd. · Jul 1997