510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970338Substantially Equivalent

Tweezer-Type Epilator

Igia Direct, Inc., Westford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970338 is the FDA 510(k) clearance record for TWEEZER-TYPE EPILATOR, a class I device, cleared for Igia Direct, Inc. on under FDA product code KCX (Epilator, High Frequency, Tweezer-Type). FDA records list one 510(k) clearance for Igia Direct, Inc. As of , FDA records show no recalls naming K970338.

Clearance record

Decision date
Received
(153 days to decision)
Product code
KCX Epilator, High Frequency, Tweezer-Type
Regulation
21 CFR 878.5360
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Igia Direct, Inc. 7 - Old Colony Dr., Westford MA
510(k) summary
Statement
Third party review
No

Clearances, product code KCX

Trailing 12 months

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

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