510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010175Substantially Equivalent

Microlight 830 Laser System

Microlight Corporation of America, Missouri City TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010175 is the FDA 510(k) clearance record for MICROLIGHT 830 LASER SYSTEM, a class II device, cleared for Microlight Corporation of America 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 3 510(k) clearances for Microlight Corporation of America, from to . As of , FDA records show no recalls naming K010175.

Clearance record

Decision date
Received
(384 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
Microlight Corporation of America 2935 Highland Lakes, Missouri City TX
510(k) summary
Summary
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