Cleared Traditional

K971953 - CONFOSCAN

K971953 is an FDA 510(k) clearance for CONFOSCAN, 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 78-day FDA review.

K971953 · Tomey Corporation USA · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
78d
Days
Class 2
Risk

K971953 is an FDA 510(k) clearance for the CONFOSCAN. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Tomey Corporation USA (Cambridge, US). The FDA issued a Cleared decision on August 14, 1997 after a review of 78 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 - K971953

510(k) Number K971953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1997
Decision Date August 14, 1997
Days to Decision 78 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
32d faster than avg
Panel avg: 110d · This submission: 78d
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 44
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K971953.
BC 900 SLIT LAMP
K982057 · Haag-Streit AG · Aug 1998
KEELER TEARSCOPE-PLUS
K973064 · Keeler Instruments, Inc. · Apr 1998
AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08
K974467 · Aesculap-Meditec North America · Feb 1998
CONFOCAL MICROSCOPE
K970414 · Con-S , Ltd. · Jul 1997
NEITZ SLIT LAMP SL-H2
K951341 · Neitz Instruments Company, Ltd. · Jun 1995
NEITZ SLIT LAMP SL-H1
K951340 · Neitz Instruments Company, Ltd. · Apr 1995