510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813208Substantially Equivalent

K60 Habitat Environment Enclosure

Kohler, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813208 is the FDA 510(k) clearance record for K60 HABITAT ENVIRONMENT ENCLOSURE, a class II device, cleared for Kohler on under FDA product code LEJ (Booth, Sun Tan). FDA records list 2 510(k) clearances for Kohler. As of , FDA records show no recalls naming K813208.

Clearance record

Decision date
Received
(43 days to decision)
Product code
LEJ Booth, Sun Tan
Regulation
21 CFR 878.4635
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kohler 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