Cleared Traditional

K970414 - CONFOCAL MICROSCOPE

K970414 is an FDA 510(k) clearance for CONFOCAL MICROSCOPE, manufactured by Con-S , Ltd.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K970414 · Con-S , Ltd. · Ophthalmic device
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Jul 1997
Decision
173d
Days
Class 2
Risk

K970414 is an FDA 510(k) clearance for the CONFOCAL MICROSCOPE. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Con-S , Ltd. (Metairie, US). The FDA issued a Cleared decision on July 15, 1997 after a review of 173 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 Con-S , Ltd. devices

FDA 510(k) Submission Details - K970414

510(k) Number K970414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1997
Decision Date July 15, 1997
Days to Decision 173 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
63d slower than avg
Panel avg: 110d · This submission: 173d
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 K970414.
KEELER TEARSCOPE-PLUS
K973064 · Keeler Instruments, Inc. · Apr 1998
AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08
K974467 · Aesculap-Meditec North America · Feb 1998
CONFOSCAN
K971953 · Tomey Corporation USA · Aug 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
SLIT LAMP, H-201
K936209 · Canon USA, Inc. · Apr 1994