Cleared Traditional

K960767 - LIGHT COMMANDER

K960767 is an FDA 510(k) clearance for LIGHT COMMANDER, manufactured by Scieran Technologies, Inc.. The device is a Class 2 Ophthalmic device with product code FCT cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K960767 · Scieran Technologies, Inc. · Ophthalmic device
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Aug 1996
Decision
182d
Days
Class 2
Risk

K960767 is an FDA 510(k) clearance for the LIGHT COMMANDER. Classified as Headlight, Fiberoptic Focusing (product code FCT), Class II - Special Controls.

Submitted by Scieran Technologies, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on August 26, 1996 after a review of 182 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4335 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Scieran Technologies, Inc. devices

FDA 510(k) Submission Details - K960767

510(k) Number K960767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1996
Decision Date August 26, 1996
Days to Decision 182 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 110d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCT Device Classification - Class 2, Special Controls

Product Code FCT Headlight, Fiberoptic Focusing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4335
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 - FCT Headlight, Fiberoptic Focusing

Devices cleared under the same product code (FCT) and FDA review panel - the closest regulatory comparables to K960767.
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