Cleared Traditional

K160477 - The Luco Hybrid OSA Appliance (FDA 510(k) Clearance)

K160477 · Luco Hybrid Osa Appliance, Inc. · Dental device
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Jul 2016
Decision
161d
Days
-
Risk

K160477 is an FDA 510(k) clearance for the The Luco Hybrid OSA Appliance. Classified as Mouthguard, Migraine/tension Headache (product code OCO).

Submitted by Luco Hybrid Osa Appliance, Inc. (Kingston, CA). The FDA issued a Cleared decision on July 29, 2016 after a review of 161 days - an extended review cycle.

This device falls under the Dental FDA review panel. 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Luco Hybrid Osa Appliance, Inc. devices

Submission Details

510(k) Number K160477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2016
Decision Date July 29, 2016
Days to Decision 161 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 127d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OCO Mouthguard, Migraine/tension Headache
Device Class -
Definition A Device To Be Used In The Prophylactic Treatment Of Medically Diagnosed Migraine Pain As Well As Migraine Associated Tension-type Headaches, By Reducing Their Signs And Symptoms Through Reduction Of Trigeminally Innervated Muscular Activity, And; For The Prevention Of Bruxism And Tmj Syndrome Through Reduction Of Trigeminally Innervated Muscular Activity.