510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K851318Substantially Equivalent

Guibor Microelectrolysis Unit 18

Galvanic Medical Instruments, Inc., Paramus NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851318 is the FDA 510(k) clearance record for GUIBOR MICROELECTROLYSIS UNIT 18, a class I device, cleared for Galvanic Medical Instruments, Inc. on under FDA product code KCW (Epilator, High Frequency, Needle-Type). FDA records list 2 510(k) clearances for Galvanic Medical Instruments, Inc., from to . As of , FDA records show no recalls naming K851318.

Clearance record

Decision date
Received
(140 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
Galvanic Medical Instruments, Inc. P.O. Box 1042, Paramus 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