Cleared Traditional

BOBES LENS SET (K945443) - FDA 510(k) Clearance

Class I Ophthalmic device.

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

Submission Details

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.

Device Classification

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.