Cleared Traditional

K945443 - BOBES LENS SET

K945443 is an FDA 510(k) clearance for BOBES LENS SET, manufactured by Bobes S.A.. The device is a Class 1 Ophthalmic device with product code HPC cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K945443 · Bobes S.A. · Ophthalmic device
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Jul 1995
Decision
254d
Days
Class 1
Risk

K945443 is an FDA 510(k) clearance for the BOBES LENS SET. Classified as Set, Lens, Trial, Ophthalmic (product code HPC), Class I - General Controls.

Submitted by Bobes S.A. (Madrid, ES). The FDA issued a Cleared decision on July 19, 1995 after a review of 254 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1405 - 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 Bobes S.A. devices

FDA 510(k) Submission Details - K945443

510(k) Number K945443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1994
Decision Date July 19, 1995
Days to Decision 254 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
144d slower than avg
Panel avg: 110d · This submission: 254d
Pathway characteristics
Predicate-based equivalence.

HPC Device Classification - Class 1, General Controls

Product Code HPC Set, Lens, Trial, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1405
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HPC Set, Lens, Trial, Ophthalmic

Devices cleared under the same product code (HPC) and FDA review panel - the closest regulatory comparables to K945443.
BURTON TRIAL LENS SET
K924786 · R.H. Burton Co. · Apr 1993
TRIAL LENS SET
K920571 · R.H. Burton Co. · May 1992
WOODLYN FULL APERTURE TRIAL LENS SET
K900478 · Woodlyn, Inc. · Feb 1990
WOODLYN CLASSIC TRIAL LENS SET
K841766 · Woodlyn, Inc. · Jun 1984
LENS SET, MENTOR TRIAL
K770389 · Codman & Shurtleff, Inc. · Mar 1977