510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K053507Substantially Equivalent

Elite Electromed L.i.t.e. 4/1

Elite Electromedical, Osage Beach MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K053507 is the FDA 510(k) clearance record for ELITE ELECTROMED L.I.T.E. 4/1, a class II device, cleared for Elite Electromedical 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 Elite Electromedical. As of , FDA records show no recalls naming K053507.

Clearance record

Decision date
Received
(89 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
Elite Electromedical 4960 Wilson Dr., Osage Beach MO
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