510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131338Substantially Equivalent

Derma Hood

Globalmedia Group, LLC, Scottsdale AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K131338 is the FDA 510(k) clearance record for DERMA HOOD, a class I device, cleared for Globalmedia Group, LLC on under FDA product code PEQ (Accessories To Examination Light). FDA's definition for product code PEQ reads: "Accessories that attach to the light and assist in magnifying, clarifying, enhancing the image being viewed". FDA records list one 510(k) clearance for Globalmedia Group, LLC. As of , FDA records show no recalls naming K131338.

Clearance record

Decision date
Received
(62 days to decision)
Product code
PEQ Accessories To Examination Light
Regulation
21 CFR 880.6320
Device class
Class I
Review panel
General Hospital
Applicant
Globalmedia Group, LLC 15020 N. 74th St., Scottsdale AZ
510(k) summary
Statement
Third party review
No

Clearances, product code PEQ

Trailing 12 months

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

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