510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010589Substantially Equivalent

Microwavae Delivery System #Mw2000

Mw Medical, Inc., Irvine CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K010589 is the FDA 510(k) clearance record for MICROWAVAE DELIVERY SYSTEM #MW2000, a class II device, cleared for Mw Medical, Inc. on under FDA product code MWY (System, Microwave, Hair Removal). FDA records list one 510(k) clearance for Mw Medical, Inc. As of , FDA records show no recalls naming K010589.

Clearance record

Decision date
Received
(20 days to decision)
Product code
MWY System, Microwave, Hair Removal
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Mw Medical, Inc. 3722 Ave. Sausalito, Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code MWY

Trailing 12 months

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

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