The following data is part of a premarket notification filed by Ultralite with the FDA for Ultralite Panelite.
| Device ID | K910091 |
| 510k Number | K910091 |
| Device Name: | ULTRALITE PANELITE |
| Classification | Lamp, Infrared, Non Heating |
| Applicant | ULTRALITE 390 FARMER CT. Lawrenceville, GA 30245 |
| Contact | William C Mcmillan |
| Correspondent | William C Mcmillan ULTRALITE 390 FARMER CT. Lawrenceville, GA 30245 |
| Product Code | IOB |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-09 |
| Decision Date | 1991-05-30 |