Cleared Traditional

K850270 - CORNEAL LIGHT SHIELD

K850270 is the FDA 510(k) clearance for CORNEAL LIGHT SHIELD by Mentor O & O, Inc.. It is a Class 1 General & Plastic Surgery device (product code HRM) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K850270 · Mentor O & O, Inc. · General & Plastic Surgery device
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May 1985
Decision
128d
Days
Class 1
Risk

K850270 is an FDA 510(k) clearance for the CORNEAL LIGHT SHIELD. Classified as Microscope, Operating & Accessories, Ac-powered, Ophthalmic (product code HRM), Class I - General Controls.

Submitted by Mentor O & O, Inc. (Hingham, US). The FDA issued a Cleared decision on May 31, 1985 after a review of 128 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4700 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Mentor O & O, Inc. devices

Submission Details

510(k) Number K850270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1985
Decision Date May 31, 1985
Days to Decision 128 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 115d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HRM Microscope, Operating & Accessories, Ac-powered, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4700
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 - HRM Microscope, Operating & Accessories, Ac-powered, Ophthalmic

All 8
Devices cleared under the same product code (HRM) and FDA review panel - the closest regulatory comparables to K850270.
S 22 INSTRUMENT STAND
K891584 · Carl Zeiss, Inc. · Jun 1989
MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50
K854440 · Keeler Instruments, Inc. · Dec 1985
CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500
K852150 · Keeler Instruments, Inc. · Jun 1985
KONAN CLINIC MICROSCOPE CLM-100-150
K844323 · Keeler Instruments, Inc. · Nov 1984
OPHTHALMIC MICROSCOPE
K822563 · Treace Medical, Inc. · Sep 1982
HAAG-STREIT SLIT LAMP 900
K792083 · Lumenis, Inc. · Nov 1979