510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833229Substantially Equivalent

Sun Bed by Verre Et Quartz Uva-France

H & M Douglas Enterprises, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833229 is the FDA 510(k) clearance record for SUN BED BY VERRE ET QUARTZ UVA-FRANCE, a class I device, cleared for H & M Douglas Enterprises, Inc. on under FDA product code FTZ (Locator, Magnetic). FDA records list one 510(k) clearance for H & M Douglas Enterprises, Inc. As of , FDA records show no recalls naming K833229.

Clearance record

Decision date
Received
(156 days to decision)
Product code
FTZ Locator, Magnetic
Regulation
21 CFR 886.4445
Device class
Class I
Review panel
Ophthalmic
Applicant
H & M Douglas Enterprises, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FTZ

Trailing 12 months

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

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