Cleared Traditional

K810117 - HALOGEN HEADLIGHT SYSTEM

K810117 is an FDA 510(k) clearance for HALOGEN HEADLIGHT SYSTEM, manufactured by Colmed, Ltd.. The device is a Class 1 Dental device with product code EBA cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K810117 · Colmed, Ltd. · Dental device
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Feb 1981
Decision
25d
Days
Class 1
Risk

K810117 is an FDA 510(k) clearance for the HALOGEN HEADLIGHT SYSTEM. Classified as Light, Surgical Headlight (product code EBA), Class I - General Controls.

Submitted by Colmed, Ltd. (Mchenry, US). The FDA issued a Cleared decision on February 10, 1981 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4630 - the FDA dental device regulatory 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.

View all Colmed, Ltd. devices

FDA 510(k) Submission Details - K810117

510(k) Number K810117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1981
Decision Date February 10, 1981
Days to Decision 25 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 127d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

EBA Device Classification - Class 1, General Controls

Product Code EBA Light, Surgical Headlight
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4630
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 - EBA Light, Surgical Headlight

Devices cleared under the same product code (EBA) and FDA review panel - the closest regulatory comparables to K810117.
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