Cleared Traditional

K870807 - BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE

K870807 is an FDA 510(k) clearance for BKS-1000 REFRACTIVE SET USE IN KERATORE..., manufactured by Allergan, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 91-day FDA review.

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

FDA 510(k) Submission Details - K870807

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 110d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

HNO Device Classification - Class 1, General Controls

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.

Regulatory Peers - HNO Keratome, Ac-powered

All 57
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K870807.
AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT
K941550 · Chiron Vision Corp. · Nov 1994
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY
K911062 · Storz Instrument Co. · May 1991
STORZ DRAEGER ROTOR KERATOME
K904845 · Storz Instrument Co. · Jan 1991
BKS-42 DISPOSABLE VACUUM TUBING PACK
K864065 · Allergan, Inc. · Dec 1986
BARRAQUER-KRUMEICH REFRACTIVE SET
K860001 · American Medical Optics · Feb 1986
ELECTRO-KERATOTOME, LINE-OPERATED
K760726 · Storz Instrument Co. · Oct 1976