510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083580Substantially Equivalent

Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301

LED Intellectual Properties LLC, Knoxville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083580 is the FDA 510(k) clearance record for ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301, a class II device, cleared for Led Intellectual Properties, LLC on under FDA product code ILY (Lamp, Infrared, Therapeutic Heating). FDA records list 12 510(k) clearances for Led Intellectual Properties, LLC, from to . As of , FDA records show no recalls naming K083580.

Clearance record

Decision date
Received
(201 days to decision)
Product code
ILY Lamp, Infrared, Therapeutic Heating
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
Led Intellectual Properties, LLC 1131 Anthem View Ln., Knoxville TN
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