The following data is part of a premarket notification filed by Atlantis Luminescent Products, Llc with the FDA for Painacea Model Xr8 Infrared Heat Lamp.
| Device ID | K051046 |
| 510k Number | K051046 |
| Device Name: | PAINACEA MODEL XR8 INFRARED HEAT LAMP |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | ATLANTIS LUMINESCENT PRODUCTS, LLC 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | James Harvey Knauss |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-04-25 |
| Decision Date | 2005-05-10 |
| Summary: | summary |