510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910091Substantially Equivalent

Ultralite Panelite

Ultralite, Lawrenceville GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910091 is the FDA 510(k) clearance record for ULTRALITE PANELITE, a class II device, cleared for Ultralite on under FDA product code IOB (Lamp, Infrared, Non Heating). FDA records list 6 510(k) clearances for Ultralite, from to . As of , FDA records show no recalls naming K910091.

Clearance record

Decision date
Received
(141 days to decision)
Product code
IOB Lamp, Infrared, Non Heating
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
Ultralite 390 Farmer Ct., Lawrenceville GA
Third party review
No

Clearances, product code IOB

Trailing 12 months

FDA records hold no clearances under product code IOB in the trailing twelve months.

FDA records show no clearances under product code IOB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IOB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260