510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K080465Substantially Equivalent

Ws Far Infrared Therapy Unit, Model # Ty-101 Series

Ws Far IR Medical Technology Co., Ltd., Flagstaff AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080465 is the FDA 510(k) clearance record for WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES, a class II device, cleared for Ws Far IR Medical Technology Co., Ltd. on under FDA product code ILY (Lamp, Infrared, Therapeutic Heating). FDA records list 2 510(k) clearances for Ws Far IR Medical Technology Co., Ltd., from to . As of , FDA records show no recalls naming K080465.

Clearance record

Decision date
Received
(148 days to decision)
Product code
ILY Lamp, Infrared, Therapeutic Heating
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
Ws Far IR Medical Technology Co., Ltd. 2904 N. Boldt Dr., Flagstaff AZ
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