510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841795Substantially Equivalent

UV 8001K, Puva 800, Puva 180/200 1000

Waldmann Lighting, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841795 is the FDA 510(k) clearance record for UV 8001K, PUVA 800, PUVA 180/200 1000, a class II device, cleared for Waldmann Lighting Co. on under FDA product code KGL (Cabinet, Phototherapy (Puva)). FDA records list 2 510(k) clearances for Waldmann Lighting Co., from to . As of , FDA records show no recalls naming K841795.

Clearance record

Decision date
Received
(120 days to decision)
Product code
KGL Cabinet, Phototherapy (Puva)
Regulation
21 CFR 878.4630
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Waldmann Lighting Co. 803 N. Front St. Suite 3, Mchenry IL
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