510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905046Substantially Equivalent

Dermabrader

Apyx Medical Corporation, St. Petersburg FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905046 is the FDA 510(k) clearance record for DERMABRADER, a class I device, cleared for Aaron Medical Industries on under FDA product code GFE (Brush, Dermabrasion, Powered). FDA records list 75 510(k) clearances for Apyx Medical Corporation, from to . As of , FDA records show no recalls naming K905046.

Clearance record

Decision date
Received
(41 days to decision)
Product code
GFE Brush, Dermabrasion, Powered
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Aaron Medical Industries 1640 Central Ave., St. Petersburg FL
Third party review
No

Clearances, product code GFE

Trailing 12 months

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

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