510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K892514Substantially Equivalent

Ahrs Epilator 629

American Hair Removal System Co., Southern Pines NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892514 is the FDA 510(k) clearance record for AHRS EPILATOR 629, a class I device, cleared for American Hair Removal System Co. on under FDA product code KCX (Epilator, High Frequency, Tweezer-Type). FDA records list one 510(k) clearance for American Hair Removal System Co. As of , FDA records show no recalls naming K892514.

Clearance record

Decision date
Received
(490 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
American Hair Removal System Co. 160 S. May St., Southern Pines NC
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