Cleared Traditional

K944910 - TOMEY EM-1000 SPECULAR MICROSCOPE

K944910 is an FDA 510(k) clearance for TOMEY EM-1000 SPECULAR MICROSCOPE, manufactured by Tomey Corporation USA. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K944910 · Tomey Corporation USA · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
48d
Days
Class 2
Risk

K944910 is an FDA 510(k) clearance for the TOMEY EM-1000 SPECULAR MICROSCOPE. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Tomey Corporation USA (Rockville, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 48 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 Tomey Corporation USA devices

FDA 510(k) Submission Details - K944910

510(k) Number K944910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1994
Decision Date November 22, 1994
Days to Decision 48 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
62d faster than avg
Panel avg: 110d · This submission: 48d
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 45
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K944910.
CONFOCAL MICROSCOPE
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K925641 · Carl Zeiss, Inc. · Sep 1993
BURTON SLIT LAMP - MODEL 850
K924783 · R.H. Burton Co. · Apr 1993