Cleared Traditional

K842515 - SURGICAL HEADLIGHT

K842515 is an FDA 510(k) clearance for SURGICAL HEADLIGHT, manufactured by Good-Lite Co.. The device is a Class 1 Dental device with product code EBA cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K842515 · Good-Lite Co. · Dental device
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Aug 1984
Decision
51d
Days
Class 1
Risk

K842515 is an FDA 510(k) clearance for the SURGICAL HEADLIGHT. Classified as Light, Surgical Headlight (product code EBA), Class I - General Controls.

Submitted by Good-Lite Co. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1984 after a review of 51 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 Good-Lite Co. devices

FDA 510(k) Submission Details - K842515

510(k) Number K842515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1984
Decision Date August 02, 1984
Days to Decision 51 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 127d · This submission: 51d
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 K842515.
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