510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K003720Substantially Equivalent

Angel of Water Colon Hydrotherapy System

Lifestream Purfication Systems, LLC, Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003720 is the FDA 510(k) clearance record for ANGEL OF WATER COLON HYDROTHERAPY SYSTEM, a class II device, cleared for Lifestream Purfication Systems, LLC on under FDA product code KPL (Colonic Irrigation System). FDA records list one 510(k) clearance for Lifestream Purfication Systems, LLC. As of , FDA records show no recalls naming K003720.

Clearance record

Decision date
Received
(570 days to decision)
Product code
KPL Colonic Irrigation System
Regulation
21 CFR 876.5220
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Lifestream Purfication Systems, LLC 6401 Meadows W. Dr., Fort Worth TX
510(k) summary
Summary
Third party review
No

Clearances, product code KPL

Trailing 12 months

FDA records hold no clearances under product code KPL in the trailing twelve months.

FDA records show no clearances under product code KPL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPL, 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