510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K181121Substantially Equivalent

Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro

Home Well Trading, Ltd., Tortola, VG / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181121 is the FDA 510(k) clearance record for Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro, a class II device, cleared for Home Well Trading, 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 2 510(k) clearances for Home Well Trading, Ltd., from to . As of , FDA records show no recalls naming K181121.

Clearance record

Decision date
Received
(59 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
Home Well Trading, Ltd. Omar Hodge Bldg., Rd. Town, Tortola, VG
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OHT

Trailing 12 months
15 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 20263
October 20260