510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160477Substantially Equivalent

The Luco Hybrid OSA Appliance

Luco Hybrid Osa Appliance, Inc., Kingston, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K160477 is the FDA 510(k) clearance record for The Luco Hybrid OSA Appliance, cleared for Luco Hybrid Osa Appliance, Inc. on under FDA product code OCO (Mouthguard, Migraine/Tension Headache). FDA's definition for product code OCO reads: "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...". FDA records list 2 510(k) clearances for Luco Hybrid Osa Appliance, Inc., from to . As of , FDA records show no recalls naming K160477.

Clearance record

Decision date
Received
(161 days to decision)
Product code
OCO Mouthguard, Migraine/Tension Headache
Device class
Unclassified
Review panel
Unknown
Applicant
Luco Hybrid Osa Appliance, Inc. 1419 Butternut Creek Rd., Kingston, CA
510(k) summary
Statement
Third party review
No

Clearances, product code OCO

Trailing 12 months

FDA records hold no clearances under product code OCO in the trailing twelve months.

FDA records show no clearances under product code OCO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OCO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260