510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243729Substantially Equivalent

Prismira

Lumos Labs, Inc., San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243729 is the FDA 510(k) clearance record for Prismira, a class II device, cleared for Lumos Labs, Inc. on under FDA product code QFT (Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder). FDA's definition for product code QFT reads: "A digital therapy device for Attention Deficit Hyperactivity Disorder (ADHD) is a software intended to provide therapy for ADHD or any of its individual symptoms as an adjunct to clinician supervised treatment". FDA records list one 510(k) clearance for Lumos Labs, Inc. As of , FDA records show no recalls naming K243729.

Clearance record

Decision date
Received
(192 days to decision)
Product code
QFT Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
Regulation
21 CFR 882.5803
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Lumos Labs, Inc. 16 Maiden Ln., San Francisco CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QFT

Trailing 12 months

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

FDA records show no clearances under product code QFT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QFT, 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