510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K973773Substantially Equivalent

Dapelle Hair Remover

Wellquest Intl., Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973773 is the FDA 510(k) clearance record for DAPELLE HAIR REMOVER, a class I device, cleared for Wellquest Intl., Inc. on under FDA product code KCX (Epilator, High Frequency, Tweezer-Type). FDA records list 2 510(k) clearances for Wellquest Intl., Inc., from to . As of , FDA records show no recalls naming K973773.

Clearance record

Decision date
Received
(76 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
Wellquest Intl., Inc. 230 Fifth Ave.,, New York NY
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