510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203665Substantially Equivalent

STOP U Model UXV Device

Pollogen Ltd, Tel Aviv, IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203665 is the FDA 510(k) clearance record for STOP U Model UXV Device, a class II device, cleared for Pollogen, Ltd. on under FDA product code PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction). FDA's definition for product code PAY reads: "An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use". FDA records list 18 510(k) clearances for Pollogen, Ltd., from to . As of , FDA records show no recalls naming K203665.

Clearance record

Decision date
Received
(71 days to decision)
Product code
PAY Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Regulation
21 CFR 878.4420
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Pollogen, Ltd. 6 Kaufman St., Tel Aviv, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PAY

Trailing 12 months
1 clearance under product code PAY in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PAY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260