510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820280Substantially Equivalent

Spectra 305/350

Ultralite, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820280 is the FDA 510(k) clearance record for SPECTRA 305/350, a class II device, cleared for Ultralite on under FDA product code KGL (Cabinet, Phototherapy (Puva)). FDA records list 6 510(k) clearances for Ultralite, from to . As of , FDA records show no recalls naming K820280.

Clearance record

Decision date
Received
(31 days to decision)
Product code
KGL Cabinet, Phototherapy (Puva)
Regulation
21 CFR 878.4630
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Ultralite 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KGL

Trailing 12 months

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

FDA records show no clearances under product code KGL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KGL, 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