510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160968Substantially Equivalent

iPulse SmoothSkin Gold Hair Removal Device

Cyden Limited, Swansea, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160968 is the FDA 510(k) clearance record for iPulse SmoothSkin Gold Hair Removal Device, a class II device, cleared for Cyden Limited 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 14 510(k) clearances for Cyden Limited, from to . As of , FDA records show no recalls naming K160968.

Clearance record

Decision date
Received
(8 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
Cyden Limited Technium 2, Kings Rd., Swansea, GB
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