510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864289Substantially Equivalent

Microprocessor Contr/multi-Needle, Galvan Epilator

Alexander Thomas, Inc., Collingswood NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864289 is the FDA 510(k) clearance record for MICROPROCESSOR CONTR/MULTI-NEEDLE, GALVAN EPILATOR, a class I device, cleared for Alexander Thomas, Inc. on under FDA product code KCW (Epilator, High Frequency, Needle-Type). FDA records list one 510(k) clearance for Alexander Thomas, Inc. As of , FDA records show no recalls naming K864289.

Clearance record

Decision date
Received
(31 days to decision)
Product code
KCW Epilator, High Frequency, Needle-Type
Regulation
21 CFR 878.5350
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Alexander Thomas, Inc. 120-2a Pacific Ave., Collingswood NJ
Third party review
No

Clearances, product code KCW

Trailing 12 months

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

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