Cleared Traditional

K893170 - VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)

K893170 is an FDA 510(k) clearance for VISTA FINOFF TRANSILLUMINATOR (AC-POWERED), manufactured by Keeler Instruments, Inc.. The device is a Class 2 Ophthalmic device with product code HJM cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K893170 · Keeler Instruments, Inc. · Ophthalmic device
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Jun 1989
Decision
41d
Days
Class 2
Risk

K893170 is an FDA 510(k) clearance for the VISTA FINOFF TRANSILLUMINATOR (AC-POWERED). Classified as Transilluminator, Ac-powered (product code HJM), Class II - Special Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on June 5, 1989 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1945 - 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 - K893170

510(k) Number K893170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1989
Decision Date June 05, 1989
Days to Decision 41 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
69d faster than avg
Panel avg: 110d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJM Device Classification - Class 2, Special Controls

Product Code HJM Transilluminator, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1945
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HJM Transilluminator, Ac-powered

All 11
Devices cleared under the same product code (HJM) and FDA review panel - the closest regulatory comparables to K893170.
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K894513 · Intl. Ophthalmic Industries Corp. · Oct 1989
RMI TRANSILLUMINATOR, MODEL 292
K812949 · Radiation Measurements, Inc. · Dec 1981
RMI TRANSILLUMINATION LIGHT METER #295
K811108 · Radiation Measurements, Inc. · Jul 1981
K893170 · VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)
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