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510(k) K905046

DERMABRADER by Aaron Medical Industries — Product Code GFE

K905046 is an FDA 510(k) premarket notification submitted by Aaron Medical Industries for the device "DERMABRADER". The FDA issued a decision of Substantially Equivalent on December 19, 1990. The device falls under product code GFE (Brush, Dermabrasion, Powered), a Class I device regulated under 21 CFR 878.4820. Aaron Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1990
Date Received
November 8, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brush, Dermabrasion, Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Aaron Medical Industries

  • K062337 — MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (October 5, 2006)
  • K061307 — BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK (July 18, 2006)
  • K060117 — BOVIE BUTTON REMOTE HAND SWITCH (February 22, 2006)
  • K022856 — BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR (February 10, 2003)
  • K021817 — AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL (July 11, 2002)
  • K020579 — AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03 (May 13, 2002)
  • K014201 — AARON REUSABLE ELECTROSURGICAL ELECTRODE (February 25, 2002)
  • K001955 — AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250 (December 22, 2000)
  • K001382 — AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR (June 27, 2000)
  • K000961 — AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE (April 19, 2000)

Other clearances for product code GFE

  • K963204 — DMS-1000C DERMOABRADER (December 9, 1996)

FDA data resources