510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802291Substantially Equivalent

Fluorescent Sun Lamp Fixture

Strato-Ray Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802291 is the FDA 510(k) clearance record for FLUORESCENT SUN LAMP FIXTURE, a class II device, cleared for Strato-Ray Co. on under FDA product code HJE (Lamp, Fluorescein, Ac-Powered). FDA records list 2 510(k) clearances for Strato-Ray Co., from to . As of , FDA records show no recalls naming K802291.

Clearance record

Decision date
Received
(42 days to decision)
Product code
HJE Lamp, Fluorescein, Ac-Powered
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Strato-Ray Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HJE

Trailing 12 months

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

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