510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K083016Substantially Equivalent

Acthyderm

Microlab Americas, Inc., Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083016 is the FDA 510(k) clearance record for ACTHYDERM, a class II device, cleared for Microlab Americas, Inc. on under FDA product code EGJ (Device, Iontophoresis, Other Uses). FDA records list one 510(k) clearance for Microlab Americas, Inc. As of , FDA records show no recalls naming K083016.

Clearance record

Decision date
Received
(250 days to decision)
Product code
EGJ Device, Iontophoresis, Other Uses
Regulation
21 CFR 890.5525
Device class
Class II
Review panel
Physical Medicine
Applicant
Microlab Americas, Inc. 1468 Harwell Ave., Crofton MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EGJ

Trailing 12 months

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

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