Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K073689Substantially Equivalent

Lep2000 Therapy System

International Medical Instruments, Inc., Houston TX / Traditional, Substantially Equivalent

K073689 is the FDA 510(k) clearance record for LEP2000 THERAPY SYSTEM, a class II device, cleared for International Medical Instruments, Inc. on under FDA product code NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy). FDA's definition for product code NHN reads: "A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and...". FDA records list one 510(k) clearance for International Medical Instruments, Inc. As of , FDA records show no recalls naming K073689.

Clearance record

Decision date
Received
(321 days to decision)
Product code
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
International Medical Instruments, Inc. 12101 Cullen Blvd., Houston TX
510(k) summary
Statement
Third party review
No

Clearances, product code NHN

Trailing 12 months
3 clearances under product code NHN in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NHN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260