510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K101894Substantially Equivalent

Healthlight Microcontroller, Minipro, Proneurolight, and Pro Unit

Bioremedi Therapeutic Systems, Inc., Potomac MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101894 is the FDA 510(k) clearance record for HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT, a class II device, cleared for Bioremedi Therapeutic Systems, Inc. on under FDA product code ILY (Lamp, Infrared, Therapeutic Heating). FDA records list one 510(k) clearance for Bioremedi Therapeutic Systems, Inc. As of , FDA records show no recalls naming K101894.

Clearance record

Decision date
Received
(198 days to decision)
Product code
ILY Lamp, Infrared, Therapeutic Heating
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
Bioremedi Therapeutic Systems, Inc. 9109 Copenhaver Dr., Potomac MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ILY

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