510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN170056Unknown

Parathyroid Detection (Model PTeye) System

Aibiomed, Corp., Santa Barbara CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN170056 is the FDA 510(k) clearance record for Parathyroid Detection (Model PTeye) System, a class II device, cleared for Aibiomed, Corp. on under FDA product code QDF (Parathyroid Autofluorescence Detection Device). FDA's definition for product code QDF reads: "An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis". FDA records list one 510(k) clearance for Aibiomed, Corp. As of , FDA records show no recalls naming DEN170056.

Clearance record

Decision date
Received
(403 days to decision)
Product code
QDF Parathyroid Autofluorescence Detection Device
Regulation
21 CFR 878.4550
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Aibiomed, Corp. 107 W. Gutierrez Sreet, Santa Barbara CA
Third party review
No

Clearances, product code QDF

Trailing 12 months

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

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