Cleared Traditional

K812706 - MILLER/NADLER GLARE TESTER

K812706 is an FDA 510(k) clearance for MILLER/NADLER GLARE TESTER, manufactured by Mosebach Electric & Supply. The device is a Class 1 Ophthalmic device with product code HOS cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K812706 · Mosebach Electric & Supply · Ophthalmic device

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Nov 1981

Decision

53d

Days

Class 1

Risk

K812706 is an FDA 510(k) clearance for the MILLER/NADLER GLARE TESTER. Classified as Projector, Ophthalmic (product code HOS), Class I - General Controls.

Submitted by Mosebach Electric & Supply (Mchenry, US). The FDA issued a Cleared decision on November 16, 1981 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1680 - 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 - K812706

510(k) Number	K812706 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 24, 1981
Decision Date	November 16, 1981
Days to Decision	53 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

57d faster than avg

Panel avg: 110d · This submission: 53d

Pathway characteristics

Predicate-based equivalence.

HOS Device Classification - Class 1, General Controls

Product Code	HOS Projector, Ophthalmic
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 886.1680

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 - HOS Projector, Ophthalmic

All 8

Devices cleared under the same product code (HOS) and FDA review panel - the closest regulatory comparables to K812706.

OPHTHALMIC PROJECTOR

K921214 · Luneau Ophtalmologie SA · Jun 1992

WOODLYN OPHTHALMIC PROJECTOR

K890992 · Woodlyn, Inc. · May 1989

BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTOR

K862519 · Bausch & Lomb, Inc. · Jul 1986

ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ

K811180 · American Optical Corp. · May 1981

PROJECTOR, ACCU-CHART ACUITY

K781658 · Bausch & Lomb, Inc. · Oct 1978

FDA 510(k) Resources - Ophthalmic

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K812706

Mosebach Electric & Supply

Mchenry, IL · US

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Ophthalmic

View all devices by Mosebach Electric & Supply →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: November 16, 1981. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: November 2026.

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