Cleared Traditional

BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE (K870807) - FDA 510(k) Clearance

Class I Ophthalmic device.

K870807 · Allergan, Inc. · Ophthalmic device
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May 1987
Decision
91d
Days
Class 1
Risk

K870807 is an FDA 510(k) clearance for the BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Allergan, Inc. (Santa Ana, US). The FDA issued a Cleared decision on May 29, 1987 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4370 - 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 Allergan, Inc. devices

Submission Details

510(k) Number K870807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1987
Decision Date May 29, 1987
Days to Decision 91 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 110d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNO Keratome, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4370
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.