510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K020243Substantially Equivalent

Laserpro 16

Eradlink, Inc., Penn Valley CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020243 is the FDA 510(k) clearance record for LASERPRO 16, a class II device, cleared for Eradlink, Inc. on under FDA product code LMA (Digitizer, Image, Radiological). FDA records list 2 510(k) clearances for Eradlink, Inc., from to . As of , FDA records show no recalls naming K020243.

Clearance record

Decision date
Received
(41 days to decision)
Product code
LMA Digitizer, Image, Radiological
Regulation
21 CFR 892.2030
Device class
Class II
Review panel
Radiology
Applicant
Eradlink, Inc. 19529 Chaparral Cir., Penn Valley CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LMA

Trailing 12 months

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

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