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
K211185Substantially Equivalent

IPL Home Use Hair Removal Device

Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd., Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211185 is the FDA 510(k) clearance record for IPL Home Use Hair Removal Device, a class II device, cleared for Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. on under FDA product code OHT (Light Based Over-The-Counter Hair Removal). FDA's definition for product code OHT reads: "Over-the-counter device uses thermal energy to kill hair follicles for hair removal". FDA records list 4 510(k) clearances for Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd., from to . As of , FDA records show no recalls naming K211185.

Clearance record

Decision date
Received
(244 days to decision)
Product code
OHT Light Based Over-The-Counter Hair Removal
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. Rm. 501, Bldg. 4, Haoer Jiashitai Technology Park, Fengtang, Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OHT

Trailing 12 months
14 clearances under product code OHT in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code OHT, trailing twelve months
MonthClearances
November 20253
December 20252
January 20260
February 20261
March 20261
April 20261
May 20263
June 20260
July 20260
August 20261
September 20262
October 20260