Cleared Traditional

K912130 - TBD KERATOSCOPE

K912130 is an FDA 510(k) clearance for TBD KERATOSCOPE, manufactured by Alcon Laboratories. The device is a Class 1 Ophthalmic device with product code HLQ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K912130 · Alcon Laboratories · Ophthalmic device
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Aug 1991
Decision
87d
Days
Class 1
Risk

K912130 is an FDA 510(k) clearance for the TBD KERATOSCOPE. Classified as Keratoscope, Ac-powered (product code HLQ), Class I - General Controls.

Submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on August 9, 1991 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1350 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K912130

510(k) Number K912130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1991
Decision Date August 09, 1991
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 110d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

HLQ Device Classification - Class 1, General Controls

Product Code HLQ Keratoscope, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1350
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 - HLQ Keratoscope, Ac-powered

All 27
Devices cleared under the same product code (HLQ) and FDA review panel - the closest regulatory comparables to K912130.
KERATOREF L60
K922253 · Luneau Ophtalmologie SA · Jun 1992
ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER)
K912740 · Visionary Systems, Inc. · Dec 1991
CCI VIDEOKERATOSCOPE/COMPARATOR
K913022 · Cci · Oct 1991
CLAS PHOTOKERATOSCOPE
K895741 · Kera-Metrics Corp. · Jul 1990
VKS-1 VIDEO KERATOSCOPE
K902012 · Computed Anatomy, Inc. · Jun 1990
MODEL 2000 INTRAOPERATIVE CORNEASCOPE
K901009 · Kera Corp. · May 1990
K912130 · TBD KERATOSCOPE
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