Cleared Traditional

K945445 - BOBES SLIT LAMP

K945445 is an FDA 510(k) clearance for BOBES SLIT LAMP, manufactured by Bobes S.A.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K945445 · Bobes S.A. · Ophthalmic device
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Oct 1995
Decision
344d
Days
Class 2
Risk

K945445 is an FDA 510(k) clearance for the BOBES SLIT LAMP. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Bobes S.A. (Madrid, ES). The FDA issued a Cleared decision on October 17, 1995 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Bobes S.A. devices

FDA 510(k) Submission Details - K945445

510(k) Number K945445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1994
Decision Date October 17, 1995
Days to Decision 344 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
234d slower than avg
Panel avg: 110d · This submission: 344d
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 77
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K945445.
CONFOCAL MICROSCOPE
K970414 · Con-S , Ltd. · Jul 1997
MODEL SL-YZ5E
K962522 · Pacific Ophthalmic Supply · Jul 1996
RODENSTOCK SLITLAMP (MODEL 5000 & 4000)
K962532 · Expertech Assoc., Inc. · Jul 1996
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