Cleared Traditional

K160477 - The Luco Hybrid OSA Appliance

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

FDA 510(k) Submission Details - K160477

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.

OCO Device Classification - Class 0,

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.