510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040662Substantially Equivalent

Vectra Genisys (Module & Transportable) and Intelect Xt (Module & Transportable) Laser Systems

Chattanooga Group, Inc., Hixson TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040662 is the FDA 510(k) clearance record for VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS, a class II device, cleared for Chattanooga Group on under FDA product code ILY (Lamp, Infrared, Therapeutic Heating). FDA records list 81 510(k) clearances for Chattanooga Group, from to . As of , FDA records show no recalls naming K040662.

Clearance record

Decision date
Received
(180 days to decision)
Product code
ILY Lamp, Infrared, Therapeutic Heating
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
Chattanooga Group 4717 Adams Rd., Hixson TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ILY

Trailing 12 months
1 clearance under product code ILY 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 ILY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260