510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K801163Substantially Equivalent

Sunburst, Sun Systems or Bc2

Sun Ray Mfg., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801163 is the FDA 510(k) clearance record for SUNBURST, SUN SYSTEMS OR BC2, a class II device, cleared for Sun Ray Mfg., Inc. on under FDA product code LEJ (Booth, Sun Tan). FDA records list one 510(k) clearance for Sun Ray Mfg., Inc. As of , FDA records show no recalls naming K801163.

Clearance record

Decision date
Received
(67 days to decision)
Product code
LEJ Booth, Sun Tan
Regulation
21 CFR 878.4635
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Sun Ray Mfg., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LEJ

Trailing 12 months

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

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