510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852684Substantially Equivalent

Waldmann F85/100w Uv21

Sylvania Lighting Products, Danvers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852684 is the FDA 510(k) clearance record for WALDMANN F85/100W UV21, a class II device, cleared for Sylvania Lighting Products on under FDA product code FTC (Light, Ultraviolet, Dermatological). FDA records list 4 510(k) clearances for Sylvania Lighting Products, from to . As of , FDA records show no recalls naming K852684.

Clearance record

Decision date
Received
(16 days to decision)
Product code
FTC Light, Ultraviolet, Dermatological
Regulation
21 CFR 878.4630
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Sylvania Lighting Products 100 Endicott St., Danvers MA
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