510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K051330Substantially Equivalent

Uvbiotek Models 3200B and 4000B

Medtek Lighting, Saint Petersburg FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K051330 is the FDA 510(k) clearance record for UVBIOTEK MODELS 3200B AND 4000B, a class II device, cleared for Medtek Lighting Corporation on under FDA product code FTC (Light, Ultraviolet, Dermatological). FDA records list 3 510(k) clearances for Medtek Lighting Corporation, from to . As of , FDA records show no recalls naming K051330.

Clearance record

Decision date
Received
(182 days to decision)
Product code
FTC Light, Ultraviolet, Dermatological
Regulation
21 CFR 878.4630
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Medtek Lighting Corporation 2840 Scherer Dr. N., Saint Petersburg FL
510(k) summary
Statement
Third party review
No

Clearances, product code FTC

Trailing 12 months
2 clearances under product code FTC 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 FTC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260