The following data is part of a premarket notification filed by Chattanooga Group with the FDA for Vectra Genisys (module & Transportable) And Intelect Xt (module & Transportable) Laser Systems.
| Device ID | K040662 |
| 510k Number | K040662 |
| Device Name: | VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | CHATTANOOGA GROUP 4717 ADAMS RD. Hixson, TN 37343 |
| Contact | Cheryl Bagwell |
| Correspondent | Cheryl Bagwell CHATTANOOGA GROUP 4717 ADAMS RD. Hixson, TN 37343 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-12 |
| Decision Date | 2004-09-08 |
| Summary: | summary |