510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963204Substantially Equivalent

Dms-1000C Dermoabrader

Aesthetic Lasers, Inc., Annapolis MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963204 is the FDA 510(k) clearance record for DMS-1000C DERMOABRADER, a class I device, cleared for Aesthetic Lasers, Inc. on under FDA product code GFE (Brush, Dermabrasion, Powered). FDA records list one 510(k) clearance for Aesthetic Lasers, Inc. As of , FDA records show no recalls naming K963204.

Clearance record

Decision date
Received
(116 days to decision)
Product code
GFE Brush, Dermabrasion, Powered
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Aesthetic Lasers, Inc. 528 College Pkwy., Suite C-1, Annapolis MD
510(k) summary
Statement
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